Cleared Traditional

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS (K990800) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990800 · Intervascular, Inc. · Cardiovascular device
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Jan 2001
Decision
670d
Days
Class 2
Risk

K990800 is an FDA 510(k) clearance for the INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARI.... Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Intervascular, Inc. (Clearwater, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 670 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Intervascular, Inc. devices

Submission Details

510(k) Number K990800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date January 08, 2001
Days to Decision 670 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
545d slower than avg
Panel avg: 125d · This submission: 670d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K990800.
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
GORE-TEX VASCULAR GRAFT
K013250 · W.L. Gore & Associates, Inc. · Oct 2001
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc. · Jul 1999
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · W.L. Gore & Associates, Inc. · Mar 1996