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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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METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L60020MR
In Commercial Distribution

  • 04540778151031 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 6.0 mm
BD-L60020MR

  • Peripheral angioplasty balloon catheter, basic
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L50020MR
In Commercial Distribution

  • 04540778151017 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 18 atm
  • Nominal Pressure; 10 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-L50020MR

  • Peripheral angioplasty balloon catheter, basic
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L40020MR
In Commercial Distribution

  • 04540778150997 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-L40020MR

  • Peripheral angioplasty balloon catheter, basic
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-L30020MR
In Commercial Distribution

  • 04540778150973 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 10 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-L30020MR

  • Peripheral angioplasty balloon catheter, basic
6mmx35mm
SILK ROAD MEDICAL, INC.
SR-6035-BC
In Commercial Distribution

  • 00811311021031 ()
SR-6035-BC

  • Peripheral angioplasty balloon catheter, basic
5.5mmx35mm
SILK ROAD MEDICAL, INC.
SR-5535-BC
In Commercial Distribution

  • 00811311021024 ()
SR-5535-BC

  • Peripheral angioplasty balloon catheter, basic
5mm X 35mm
SILK ROAD MEDICAL, INC.
SR-5035-BC
In Commercial Distribution

  • 00811311021017 ()
SR-5035-BC

  • Peripheral angioplasty balloon catheter, basic
4.5mm X 35mm
SILK ROAD MEDICAL, INC.
SR-4535-BC
In Commercial Distribution

  • 00811311021000 ()
SR-4535-BC

  • Peripheral angioplasty balloon catheter, basic
4mm X 35mm
SILK ROAD MEDICAL, INC.
SR-4035-BC
In Commercial Distribution

  • 00811311020997 ()
SR-4035-BC

  • Peripheral angioplasty balloon catheter, basic
6mm X 25mm
SILK ROAD MEDICAL, INC.
SR-6025-BC
In Commercial Distribution

  • 00811311020966 ()
SR-6025-BC

  • Peripheral angioplasty balloon catheter, basic
5.5mm X 25mm
SILK ROAD MEDICAL, INC.
SR-5525-BC
In Commercial Distribution

  • 00811311020959 ()
SR-5525-BC

  • Peripheral angioplasty balloon catheter, basic
5mm X 25mm
SILK ROAD MEDICAL, INC.
SR-5025-BC
In Commercial Distribution

  • 00811311020942 ()
SR-5025-BC

  • Peripheral angioplasty balloon catheter, basic
4.5mm X 25mm
SILK ROAD MEDICAL, INC.
SR-4525-BC
In Commercial Distribution

  • 00811311020935 ()
SR-4525-BC

  • Peripheral angioplasty balloon catheter, basic
4mm x 25mm
SILK ROAD MEDICAL, INC.
SR-4025-BC
In Commercial Distribution

  • 00811311020928 ()
SR-4025-BC

  • 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
Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
M001145100
In Commercial Distribution

  • 08714729096146 ()

  • 75 cm Effective Length
  • 12 mm Diameter
  • 4 cm Length


  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
M001105630
In Commercial Distribution

  • 08714729270560 ()

  • 3.5 mm Diameter
  • 150 cm Effective Length
  • 20 mm Length


  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
M001105410
In Commercial Distribution

  • 08714729182672 ()

  • 3.5 mm Diameter
  • 135 cm Effective Length
  • 100 mm Length


  • Peripheral angioplasty balloon catheter, basic
Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORPORATION
M001105170
In Commercial Distribution

  • 08714729182665 ()

  • 100 mm Length
  • 90 cm Effective Length
  • 3.5 mm Diameter


  • Peripheral angioplasty balloon catheter, basic
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