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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.
4.0x12mm
In Commercial Distribution
- 00195451000034 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 4.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL4012
- 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.
3.5x12mm
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.
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
PUMP MMT-1884G 780G 6.21 GS
MEDTRONIC MINIMED, INC.
MMT-1884G
In Commercial Distribution
- 00199150003686 ()
- Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution
- 00198715728941 ()
- Faecal specimen collection kit IVD, home-use
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
RENATA MEDICAL, INC.
FG-0002
In Commercial Distribution
- 00196852805037 ()
- Bare-metal aortic stent
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
RENATA MEDICAL, INC.
FG-0001
In Commercial Distribution
- 00196852801862 ()
- Bare-metal aortic stent
(resin beige)
Advanced Bionics Corporation
CI-5294
In Commercial Distribution
- 00197420013236 ()
- Cochlear implant/auditory brainstem implant sound processor
(resin beige)
Advanced Bionics Corporation
CI-5294
In Commercial Distribution
- 00197420013229 ()
- Cochlear implant/auditory brainstem implant sound processor
(velvet black)
Advanced Bionics Corporation
CI-5294
In Commercial Distribution
- 00197420013212 ()
- Cochlear implant/auditory brainstem implant sound processor