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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FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm
Verge Medical, Inc.
OAB7019BA
In Commercial Distribution

  • M917OAB7019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 7.0mm
OAB7019BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 17mm
Verge Medical, Inc.
OAB6019BA
In Commercial Distribution

  • M917OAB6019BA0 ()

  • Distal Balloon Diameter: 6.0mm
  • Distal Balloon Length: 17mm
  • Catheter Length: 135cm
OAB6019BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 12mm
Verge Medical, Inc.
OAB6014BA
In Commercial Distribution

  • M917OAB6014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 6.0mm
OAB6014BA

  • Peripheral angioplasty balloon catheter, basic
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
2290-60100-A
Not in Commercial Distribution

  • M37022906010018 ()

  • Length: 100 Millimeter
  • Outer Diameter: 6.0 Millimeter
2290-60100

  • Peripheral angioplasty balloon catheter, basic
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
2290-50100-A
Not in Commercial Distribution

  • M37022905010017 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.0 Millimeter
2290-50100

  • Peripheral angioplasty balloon catheter, basic
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
2290-40100-A
Not in Commercial Distribution

  • M37022904010016 ()

  • Length: 100 Millimeter
  • Outer Diameter: 4.0 Millimeter
2290-40100

  • Peripheral angioplasty balloon catheter, basic
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
2237-60100-A
Not in Commercial Distribution

  • M37022376010019 ()

  • Length: 100 Millimeter
  • Outer Diameter: 6.0 Millimeter
2237-60100

  • Peripheral angioplasty balloon catheter, basic
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
2237-50100-A
Not in Commercial Distribution

  • M37022375010018 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.0 Millimeter
2237-50100

  • Peripheral angioplasty balloon catheter, basic
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