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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.
5.0mm x 60mm
Not in Commercial Distribution

  • M732M5IVL50600 ()

  • 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

  • Ultrasound thrombolysis system 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.
4.5mm x 60mm
Not in Commercial Distribution

  • M732M5IVL45600 ()

  • 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

  • Ultrasound thrombolysis system 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.
4.0mm x 60mm
Not in Commercial Distribution

  • M732M5IVL40600 ()

  • 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

  • Ultrasound thrombolysis system 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.
3.5mm x 60mm
Not in Commercial Distribution

  • M732M5IVL35600 ()

  • 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

  • Ultrasound thrombolysis system catheter, peripheral
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
18cm X 2.5cm
In Commercial Distribution

  • M724IGS18X251 ()
IGS-18X25

  • Scar-management dressing, reusable
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
12cm x 15cm
In Commercial Distribution

  • M724IGS12151 ()
IGS-12-15

  • Scar-management dressing, reusable
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
6cm x 10cm
In Commercial Distribution

  • M724IGS06101 ()
IGS-06-10

  • Scar-management dressing, reusable
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
18cm X 20cm
In Commercial Distribution

  • M724GS18X20T1 ()
GS-18X20T

  • Scar-management dressing, reusable
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
18cm X 2.5cm
In Commercial Distribution

  • M724GS18X025T1 ()
GS-18X25T

  • Scar-management dressing, reusable
Scar Management, Gel Sheet
IMPLANTECH ASSOCIATES, INC.
18cm X 2.5cm
In Commercial Distribution

  • M724GS18X0251 ()
GS-18X25

  • Scar-management dressing, reusable
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