Cleared Traditional

K004012 - IMPRA CARBOFLO EPTFE VASCULAR GRAFTS

K004012 is an FDA 510(k) clearance for IMPRA CARBOFLO EPTFE VASCULAR GRAFTS, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DYF cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K004012 · Impra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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May 2001
Decision
138d
Days
Class 2
Risk

K004012 is an FDA 510(k) clearance for the IMPRA CARBOFLO EPTFE VASCULAR GRAFTS. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on May 14, 2001 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Impra, Inc. devices

FDA 510(k) Submission Details - K004012

510(k) Number K004012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date May 14, 2001
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYF Device Classification - Class 2, Special Controls

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 20
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K004012.
ADVANTA SUPER SOFT GRAFT
K000504 · Atrium Medical Corp. · Mar 2000
ADVANTA GRAFT (<6MM)
K992958 · Atrium Medical Corp. · Oct 1999
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · W.L. Gore & Associates, Inc. · Sep 1999
ADVANTA GRAFT
K992441 · Atrium Medical Corp. · Aug 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · Possis Medical, Inc. · Feb 1999
DISTAFLO BYPASS GRAFT
K983769 · Impra, Inc. · Dec 1998