Cleared Traditional

K013651 - INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

K013651 is an FDA 510(k) clearance for INTERGARD HEMABRIDGE COLLAGEN COATED VA..., manufactured by Intervascular. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K013651 · Intervascular · Cardiovascular device
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Feb 2002
Decision
113d
Days
Class 2
Risk

K013651 is an FDA 510(k) clearance for the INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC AR.... Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Intervascular (Wellesley, US). The FDA issued a Cleared decision on February 27, 2002 after a review of 113 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.

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FDA 510(k) Submission Details - K013651

510(k) Number K013651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date February 27, 2002
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
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 145
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K013651.
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
ADVANTA SST GRAFT (>_6MM)
K010516 · Atrium Medical Corp. · May 2001