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510(k) K981079

VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT by Impra, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
March 24, 1998
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 Impra, Inc.

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (March 27, 2001)
  • K991027 — BI-DIRECTIONAL TUNNELER (April 22, 1999)
  • K983769 — DISTAFLO BYPASS GRAFT (December 15, 1998)
  • K983861 — DISTAFLO BYPASS GRAFT (November 24, 1998)
  • K983064 — IMPRA HIGH POROSITY GRAFT (November 19, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (April 15, 1997)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)
  • K964197 — IMPRA CARBOFLO EPTFE VASCULAR GRAFT (January 2, 1997)

Other clearances for product code DSY

  • K252277 — Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (October 20, 2025)
  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • 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)