Cleared Traditional

K933590 - BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT

K933590 is an FDA 510(k) clearance for BAXTER REINFORCED EXPANDED PTFE VASCULA..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K933590 · Baxter Healthcare Corp · Cardiovascular device
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Jan 1994
Decision
184d
Days
Class 2
Risk

K933590 is an FDA 510(k) clearance for the BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 184 days - an extended review cycle.

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 Healthcare Corp devices

FDA 510(k) Submission Details - K933590

510(k) Number K933590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1993
Decision Date January 26, 1994
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 155
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K933590.
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
DIASTAT VASCULAR ACCESS GRAFT
K940062 · W.L. Gore & Associates, Inc. · May 1994
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · W.L. Gore & Associates, Inc. · Dec 1993
BARD PTFE VASCULAR GRAFT
K933204 · C.R. Bard, Inc. · Oct 1993
ATRIUM'S HYBRID PTFE
K925123 · Atrium Medical Corp. · May 1993