IMPRA CARBOFLO EPTFE VASCULAR GRAFTS— 510(k) K004012

Name: FDA 510(k) clearance K004012
Creator: U.S. Food and Drug Administration
Published: 2001-05-14

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K004012 for IMPRA CARBOFLO EPTFE VASCULAR GRAFTS, Substantially Equivalent on 2001-05-14. 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: 2000-12-27
Decision date: 2001-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYF

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K000504 — ADVANTA SUPER SOFT GRAFT2000-03-01
K992958 — ADVANTA GRAFT (<6MM)1999-10-01
K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT1999-09-08
K992441 — ADVANTA GRAFT1999-08-20
K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 314511999-02-01

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.