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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.5 x 60mm
In Commercial Distribution


  • Introducer Sheath Compatibility: 6 French
  • Catheter Working Length: 110 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Diameter: 5.5 Millimeter
M5IVL5560

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.0 x 60mm
In Commercial Distribution


  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Balloon Diameter: 5.0 Millimeter
M5IVL5060

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
4.5 x 60mm
In Commercial Distribution


  • Balloon Diameter: 4.5 Millimeter
  • Introducer Sheath Compatibility: 6 French
  • Catheter Working Length: 110 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
M5IVL4560

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
4.0 x 60mm
In Commercial Distribution


  • Balloon Diameter: 4.0 Millimeter
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
M5IVL4060

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
3.5 x 60mm
In Commercial Distribution


  • Introducer Sheath Compatibility: 6 French
  • Catheter Working Length: 110 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Diameter: 3.5 Millimeter
M5IVL3560

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
4.0 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.054 Inch
  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL4040

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
3.5 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.054 Inch
  • Balloon Diameter: 3.5 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL3540

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
3.0 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.052 Inch
  • Balloon Diameter: 3.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL3040

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
2.5 x 40mm
In Commercial Distribution


  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
  • Balloon Length: 40 Millimeter
  • Balloon Diameter: 2.5 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.052 Inch
  • Catheter Working Length: 135 Centimeter
S4IVL2540

  • Intravascular lithotripsy system balloon catheter, peripheral
24 x 65 Metaphyseal Stem
SIGNAL MEDICAL CORPORATION
24 x 65
In Commercial Distribution

  • B04622051024650 ()
22-05-102465

  • Knee femur stem prosthesis
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