Cleared Traditional

K940816 - BARD EXPANDED PTFE VASCULAR GRAFT

K940816 is the FDA 510(k) clearance for BARD EXPANDED PTFE VASCULAR GRAFT by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K940816 · C.R. Bard, Inc. · Cardiovascular device
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Jun 1994
Decision
100d
Days
Class 2
Risk

K940816 is an FDA 510(k) clearance for the BARD(R) EXPANDED PTFE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Woburn, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 100 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K940816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 22, 1994
Decision Date June 02, 1994
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater 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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 92
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K940816.
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · C.R. Bard, Inc. · Dec 1995
DIASTAT VASCULAR ACCESS GRAFT
K953288 · W.L. Gore & Associates, Inc. · Oct 1995
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K941981 · W.L. Gore & Associates, Inc. · Jul 1994
AOR-TEX VASCULAR GRAFT
K933987 · W.L. Gore & Associates, Inc. · May 1994
DIASTAT VASCULAR ACCESS GRAFT
K940062 · W.L. Gore & Associates, Inc. · May 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · Baxter Healthcare Corp · Jan 1994