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The Shockwave C2+ Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation 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+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, 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.
3.5x12mm
In Commercial Distribution
- 00195451000027 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 3.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL3512
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation 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+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, 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.
3.0x12mm
In Commercial Distribution
- 00195451000010 ()
- Balloon Length: 12 Centimeter
- Balloon Diameter: 3.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL3012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation 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+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, 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.
2.5x12mm
In Commercial Distribution
- 00195451000003 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 2.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL2512
- Intravascular lithotripsy system balloon catheter, coronary
LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-40060-US-21
In Commercial Distribution
- 00850041730110 ()
- Arteriovenous endovascular stent-graft
LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-35060-US-21
In Commercial Distribution
- 00850041730097 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55060-US-21
In Commercial Distribution
- 00850041730073 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55100-US-21
In Commercial Distribution
- 00850041730059 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55150-US-21
In Commercial Distribution
- 00850041730042 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55200-US-21
In Commercial Distribution
- 00850041730035 ()
- Arteriovenous endovascular stent-graft
GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
BAXTER HEALTHCARE CORPORATION
1501341
Not in Commercial Distribution
- 50085412086304 ()
- 00085412086309 ()
1501341
- Collagen haemostatic agent, non-antimicrobial