Cleared Traditional

K964877 - IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

K964877 is an FDA 510(k) clearance for IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT, 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 105-day FDA review.

K964877 · Impra, Inc. · Cardiovascular device
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Mar 1997
Decision
105d
Days
Class 2
Risk

K964877 is an FDA 510(k) clearance for the IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT. 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 March 20, 1997 after a review of 105 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 - K964877

510(k) Number K964877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 05, 1996
Decision Date March 20, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K964877.
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · Possis Medical, Inc. · Feb 1999
DISTAFLO BYPASS GRAFT
K983769 · Impra, Inc. · Dec 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981076 · Impra, Inc. · May 1998
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1997
DIASTAT VASCULAR ACCESS GRAFT
K955533 · W.L. Gore & Associates, Inc. · May 1996
DIASTAT VASCULAR ACCESS GRAFT
K953287 · W.L. Gore & Associates, Inc. · Oct 1995