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510(k) K013022

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS by Sulzer Carbomedics, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
September 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

Other clearances by Sulzer Carbomedics, Inc.

  • K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (December 17, 2002)
  • K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR700 (April 23, 2002)
  • K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (January 25, 2001)
  • K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (December 29, 1999)
  • K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (October 12, 1999)
  • K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (August 4, 1998)
  • K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (April 14, 1998)

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  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft (March 28, 2024)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (January 17, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K213845 — HeRO Graft (August 15, 2022)