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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 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
Shipping box carton containing 4 boxes of 10 individual devices; Not commercialized
Stockert GmbH
20624
In Commercial Distribution

  • 04260166374360 ()
M004GEN100206241

  • Cardiac ablation system irrigation tubing set
No Description
Stockert GmbH
20625
In Commercial Distribution

  • 04260166374353 ()
M004GEN100206251

  • Cardiac ablation system irrigation tubing set
Only commercialized as part of the 10 PK
Stockert GmbH
20626
In Commercial Distribution

  • 04260166374346 ()
M004GEN100206260

  • Cardiac ablation system irrigation tubing set
LEAD 6947M97 US DF4 RCMCRD
MEDTRONIC, INC.
6947M97
In Commercial Distribution

  • 00763000180355 ()

  • Length: 97.0 Centimeter


  • Endocardial defibrillation lead
LEAD 6947M72 US DF4 RCMCRD
MEDTRONIC, INC.
6947M72
In Commercial Distribution

  • 00763000180348 ()

  • Length: 72.0 Centimeter


  • Endocardial defibrillation lead
LEAD 6947M49 US DF4 RCMCRD
MEDTRONIC, INC.
6947M49
In Commercial Distribution

  • 00763000180331 ()

  • Length: 49.0 Centimeter


  • Endocardial defibrillation lead
LEAD 6947M62 MRI US DF4 RCMCRD
MEDTRONIC, INC.
6947M62
In Commercial Distribution

  • 00763000180324 ()

  • Length: 62.0 Centimeter


  • Endocardial defibrillation lead
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