Cleared Traditional

K990503 - SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS

K990503 is an FDA 510(k) clearance for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS, manufactured by Sulzermedica. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K990503 · Sulzermedica · Cardiovascular device
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Dec 1999
Decision
295d
Days
Class 2
Risk

K990503 is an FDA 510(k) clearance for the SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Sulzermedica (Austin, US). The FDA issued a Cleared decision on December 9, 1999 after a review of 295 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 Sulzermedica devices

FDA 510(k) Submission Details - K990503

510(k) Number K990503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1999
Decision Date December 09, 1999
Days to Decision 295 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
170d slower than avg
Panel avg: 125d · This submission: 295d
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 139
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K990503.
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · Impra, Inc. · Mar 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
K990800 · Intervascular, Inc. · Jan 2001
ADVANTA SUPER SOFT GRAFT
K000499 · Atrium Medical Corp. · Mar 2000
ADVANTA GRAFT (>6MM)
K992960 · Atrium Medical Corp. · Oct 1999
ADVANTA GRAFT
K992443 · Atrium Medical Corp. · Aug 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc. · Jul 1999