Cleared Traditional

K933204 - BARD PTFE VASCULAR GRAFT

K933204 is the FDA 510(k) clearance for BARD 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 118-day FDA review.

K933204 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1993
Decision
118d
Days
Class 2
Risk

K933204 is an FDA 510(k) clearance for the BARD 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. (Billerica, US). The FDA issued a Cleared decision on October 27, 1993 after a review of 118 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 K933204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date October 27, 1993
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 K933204.
DIASTAT VASCULAR ACCESS GRAFT
K940062 · W.L. Gore & Associates, Inc. · May 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · Baxter Healthcare Corp · Jan 1994
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · W.L. Gore & Associates, Inc. · Dec 1993
ATRIUM'S HYBRID PTFE
K925123 · Atrium Medical Corp. · May 1993
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · W.L. Gore & Associates, Inc. · Nov 1992
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · Medtronic Vascular · Nov 1991