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 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.
4.0 x 12mm
In Commercial Distribution

  • 00195451000119 ()

  • Balloon Proximal Outer Diameter (OD): 0.047 Inch
  • Balloon Diameter: 4.0 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
C2IVL4012

  • Intravascular lithotripsy system balloon catheter, coronary
Ligature Sleeve
Oscor Inc.
664760-303
In Commercial Distribution

  • 20885672008349 ()
  • 00885672008345 ()

  • Lumen/Inner Diameter: 2.1 Millimeter
LS21-10

  • Endocardial defibrillation lead
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
LEAD 6947M55 MRI US DF4 RCMCRD
MEDTRONIC, INC.
6947M55
In Commercial Distribution

  • 00763000180317 ()

  • Length: 55.0 Centimeter


  • Endocardial defibrillation lead
LEAD 694765 SPRINT US MRI RCMCRD
MEDTRONIC, INC.
694765
In Commercial Distribution

  • 00763000180263 ()

  • Length: 65.0 Centimeter


  • Endocardial defibrillation lead
LEAD 694758 SPRINT US MRI RCMCRD
MEDTRONIC, INC.
694758
In Commercial Distribution

  • 00763000180256 ()

  • Length: 58.0 Centimeter


  • Endocardial defibrillation lead
LEAD 6935M97 US DF4 RCMCRD
MEDTRONIC, INC.
6935M97
In Commercial Distribution

  • 00763000180157 ()

  • Length: 97.0 Centimeter


  • Endocardial defibrillation lead
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