Cleared Traditional

K002007 - SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

K002007 is an FDA 510(k) clearance for SULZER VASCUTEK GELSOFT ERS VASCULAR PR..., 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 206-day FDA review.

K002007 · Sulzer Carbomedics, Inc. · Cardiovascular device
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Jan 2001
Decision
206d
Days
Class 2
Risk

K002007 is an FDA 510(k) clearance for the SULZER VASCUTEK GELSOFT ERS 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 January 25, 2001 after a review of 206 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 - K002007

510(k) Number K002007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date January 25, 2001
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
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 K002007.
ADVANTA SST GRAFT (>_6MM)
K010516 · Atrium Medical Corp. · May 2001
ADVANTA SST GRAFT (<6MM)
K010517 · Atrium Medical Corp. · May 2001
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
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K990503 · Sulzermedica · Dec 1999