Cleared Special

K983819 - INTERGARD KNITTED ULTRA THIN COLLAGEN C...

K983819 is the FDA 510(k) clearance for INTERGARD KNITTED ULTRA THIN COLLAGEN C... by Intervascular, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Special 510(k) pathway after a 26-day FDA review.

K983819 · Intervascular, Inc. · Cardiovascular device
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Nov 1998
Decision
26d
Days
Class 2
Risk

K983819 is an FDA 510(k) clearance for the INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID P.... 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 November 24, 1998 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intervascular, Inc. devices

Submission Details

510(k) Number K983819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1998
Decision Date November 24, 1998
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 107
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K983819.
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · Atrium Medical Corp. · Jun 1999
BI-DIRECTIONAL TUNNELER
K991027 · Impra, Inc. · Apr 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · Possis Medical, Inc. · Feb 1999
DISTAFLO BYPASS GRAFT
K983861 · Impra, Inc. · Nov 1998
IMPRA HIGH POROSITY GRAFT
K983064 · Impra, Inc. · Nov 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · Impra, Inc. · May 1998