Cleared Traditional

K013022 - SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

K013022 is an FDA 510(k) clearance for SULZER VASCUTEK GELWEAVE VALSALVA VASCU..., manufactured by Sulzer Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K013022 · Sulzer Carbomedics, Inc. · Cardiovascular device
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Jun 2002
Decision
279d
Days
Class 2
Risk

K013022 is an FDA 510(k) clearance for the SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Sulzer Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 13, 2002 after a review of 279 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 Sulzer Carbomedics, Inc. devices

FDA 510(k) Submission Details - K013022

510(k) Number K013022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2001
Decision Date June 13, 2002
Days to Decision 279 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 125d · This submission: 279d
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 K013022.
GELSOFT PLUS ERS
K034010 · Vascutek, Ltd. · Feb 2004
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC · Dec 2003
EPTFE VASCULAR PROSTHESIS
K030999 · Vascutek, Ltd. · Apr 2003
ADVANTA SST BIFURCATED GRAFT
K020767 · Atrium Medical Corp. · Apr 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · Atrium Medical Corp. · Jan 2002
GORE-TEX VASCULAR GRAFT
K013250 · W.L. Gore & Associates, Inc. · Oct 2001