Cleared Traditional

K954582 - BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)

K954582 is an FDA 510(k) clearance for BARD EXPANDED PTFE VASCULAR GRAFT(MODIF..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K954582

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.

DSY Device Classification - Class 2, Special Controls

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 152
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K954582.
VASCUTEK GRAFT SIZER SET
K955588 · Carbomedics, Inc. · Mar 1996
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230 · Vascutek, Ltd. · Feb 1996
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · Vascutek, Ltd. · 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
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994