VASCULAR GRAFT PROST. OF EXPANDED PTFE— 510(k) K791810

Name: FDA 510(k) clearance K791810
Creator: U.S. Food and Drug Administration
Published: 1979-10-09

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K791810 for VASCULAR GRAFT PROST. OF EXPANDED PTFE, Substantially Equivalent on 1979-10-09. 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: 1979-09-14
Decision date: 1979-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYF

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K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT1999-09-08
K992441 — ADVANTA GRAFT1999-08-20

More clearances from Impra, Inc.

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K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS2001-03-27
K991027 — BI-DIRECTIONAL TUNNELER1999-04-22
K983769 — DISTAFLO BYPASS GRAFT1998-12-15
K983861 — DISTAFLO BYPASS GRAFT1998-11-24
K983064 — IMPRA HIGH POROSITY GRAFT1998-11-19

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