Cleared Traditional

K944858 - BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS

K944858 is an FDA 510(k) clearance for BAXTER EPTFE EXTERNALLY SUPPORTED VASCU..., manufactured by Baxter Edwards. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K944858 · Baxter Edwards · Cardiovascular device
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Jan 1995
Decision
94d
Days
Class 2
Risk

K944858 is an FDA 510(k) clearance for the BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on January 5, 1995 after a review of 94 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 Baxter Edwards devices

FDA 510(k) Submission Details - K944858

510(k) Number K944858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 03, 1994
Decision Date January 05, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
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 140
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K944858.
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · Vascutek, Ltd. · Dec 1995
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
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994
AOR-TEX VASCULAR GRAFT
K933987 · W.L. Gore & Associates, Inc. · May 1994