VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT— 510(k) K981076

Name: FDA 510(k) clearance K981076
Creator: U.S. Food and Drug Administration
Published: 1998-05-07

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K981076 for VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT, Substantially Equivalent on 1998-05-07. Applicant: Impra, Inc.. Device class: 2.

Clearance details

Applicant: Impra, Inc.
Product code: Code DYF
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1998-03-24
Decision date: 1998-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.