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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.
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
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.
2.5 x 12mm
In Commercial Distribution
- 00195451000089 ()
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Balloon Diameter: 2.5 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
C2IVL2512
- Intravascular lithotripsy system balloon catheter, coronary
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
- 00195451000065 ()
- M732S4IVL35400 ()
- 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
- 00195451000058 ()
- M732S4IVL30400 ()
- 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
- 00195451000041 ()
- M732S4IVL25400 ()
- 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
PowerHeal Single Layer, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution
- 00810198031577 ()
- Length: 4 Inch
- Width: 4 Inch
PSK-4040
- Bioelectric wound dressing
PowerHeal Single Layer, 2" x 2"
Vomaris Wound Care, Inc.
2" x 2"
In Commercial Distribution
- 00810198031560 ()
- Length: 2 Inch
- Width: 2 Inch
PSK-0202
- Bioelectric wound dressing
PowerHeal 3-layer clear adhesive, 2.3 x 3.5
Vomaris Wound Care, Inc.
2.3" x 3.5"
In Commercial Distribution
- 00810198031522 ()
- Length: 2.3 Inch
- Width: 3.5 Inch
PFK-2335
- Bioelectric wound dressing
Procellera Single Layer Rx, 5" x 5"
Vomaris Wound Care, Inc.
5" x 5"
In Commercial Distribution
- 00894318002579 ()
- 00810198030808 ()
- 00810198030815 ()
VSR-0505
- Bioelectric wound dressing