Cleared Traditional

K954582 - BARD EXPANDED PTFE VASCULAR GRAFT(MODIF...

K954582 is the FDA 510(k) clearance for BARD EXPANDED PTFE VASCULAR GRAFT(MODIF... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K954582 · C.R. Bard, Inc. · Cardiovascular device
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Dec 1995
Decision
91d
Days
Class 2
Risk

K954582 is an FDA 510(k) clearance for the BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION). Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on December 7, 1995 after a review of 91 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 K954582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 07, 1995
Decision Date December 07, 1995
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K954582.
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
K955460 · Meadox Medicals, Div. Boston Scientific Corp. · May 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · W.L. Gore & Associates, Inc. · Mar 1996
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
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994