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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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AngioSculpt® PTCA Scoring Balloon Catheter
Spectranetics Corporation
2027-2515
In Commercial Distribution

  • 00813132021054 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 15 Millimeter
2027-2515

  • Coronary angioplasty balloon catheter, cutting/scoring
AngioSculpt® PTCA Scoring Balloon Catheter
Spectranetics Corporation
2027-2015
In Commercial Distribution

  • 00813132021023 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 15 Millimeter
2027-2015

  • Coronary angioplasty balloon catheter, cutting/scoring
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs and iliac extensions as required. The TriVascular Ovation iX Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB3480J1 ()

  • Outer Diameter: 34 Millimeter
  • Catheter Gauge: 15 French
TV-AB3480-J

  • Abdominal aorta endovascular stent-graft
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Aortic Body
In Commercial Distribution

  • M701TVAB3480E1 ()

  • Catheter Gauge: 15 French
  • Outer Diameter: 34 Millimeter
TV-AB3480-E

  • Abdominal aorta endovascular stent-graft
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815400
In Commercial Distribution

  • 00191506014773 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 15 Millimeter
H7493960815400

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815350
In Commercial Distribution

  • 00191506014766 ()

  • Balloon Diameter: 3.50 Millimeter
  • Balloon Length: 15 Millimeter
H7493960815350

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815300
In Commercial Distribution

  • 00191506014759 ()

  • Balloon Length: 15 Millimeter
  • Balloon Diameter: 3 Millimeter
H7493960815300

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815270
In Commercial Distribution

  • 00191506014742 ()

  • Balloon Length: 15 Millimeter
  • Balloon Diameter: 2.75 Millimeter
H7493960815270

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815250
In Commercial Distribution

  • 00191506014735 ()

  • Balloon Diameter: 2.50 Millimeter
  • Balloon Length: 15 Millimeter
H7493960815250

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960815220
In Commercial Distribution

  • 00191506014728 ()

  • Balloon Diameter: 2.25 Millimeter
  • Balloon Length: 15 Millimeter
H7493960815220

  • Coronary angioplasty balloon catheter, drug-coated
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