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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.
4.5 x 60mm
In Commercial Distribution
- 00195451000140 ()
- 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
- 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
- 00195451000126 ()
- 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
- Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.5 x 12mm
In Commercial Distribution
- 00195451000102 ()
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Balloon Diameter: 3.5 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3512
- Intravascular lithotripsy system balloon catheter, coronary
For transition of irrigation solution.
Fresenius Kabi AG
1 D/X
In Commercial Distribution
- 04250273756012 ()
- 04250273756005 ()
2877001
- Single-administration urethral drainage/irrigation catheter
For transition of irrigation solution.
Fresenius Kabi AG
2 D/X
In Commercial Distribution
- 04250273755794 ()
- 04250273755787 ()
2877201
- Single-administration urethral drainage/irrigation catheter
For transition of irrigation solution.
Fresenius Kabi AG
4 D/X
In Commercial Distribution
- 04250273755756 ()
- 04250273755749 ()
2848021
- Single-administration urethral drainage/irrigation catheter
For transition of irrigation solution.
Fresenius Kabi AG
2 D/X
In Commercial Distribution
- 04250273755725 ()
- 04250273755732 ()
2848011
- Electric infusion pump administration set, single-use
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.
7.0 x 60mm
In Commercial Distribution
- 00195451000195 ()
- M732M5IVL70600 ()
- Catheter Working Length: 110 Centimeter
- Balloon Diameter: 7.0 Millimeter
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
- Balloon Length: 60 Millimeter
- Introducer Sheath Compatibility: 7 French
- Balloon Proximal Outer Diameter (OD): 0.072 Inch
- Guidewire Diameter: 0.014 Inch
M5IVL7060
- 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.
6.5 x 60mm
In Commercial Distribution
- 00195451000188 ()
- M732M5IVL65600 ()
- Catheter Working Length: 110 Centimeter
- Balloon Length: 60 Millimeter
- Balloon Rated Burst Pressure: 10 Atmosphere
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Guidewire Diameter: 0.014 Inch
- Balloon Proximal Outer Diameter (OD): 0.072 Inch
- Introducer Sheath Compatibility: 7 French
- Balloon Diameter: 6.5 Millimeter
M5IVL6560
- 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
- 00195451000157 ()
- 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
- Intravascular lithotripsy system balloon catheter, peripheral