Cleared Traditional

K964625 - HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES

K964625 is an FDA 510(k) clearance for HEMAPATCH VASCULAR PATCHES, manufactured by Intervascular, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K964625 · Intervascular, Inc. · Cardiovascular device
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May 1997
Decision
171d
Days
Class 2
Risk

K964625 is an FDA 510(k) clearance for the HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES. 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 May 5, 1997 after a review of 171 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 Intervascular, Inc. devices

FDA 510(k) Submission Details - K964625

510(k) Number K964625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 15, 1996
Decision Date May 05, 1997
Days to Decision 171 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 125d · This submission: 171d
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 159
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K964625.
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · Impra, Inc. · May 1998
UNI-GRAFT K DV
K963790 · Atrium Medical Corp. · Jul 1997
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K970843 · Intervascular, Inc. · Jun 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · Impra, Inc. · Apr 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · Vascutek, Ltd. · Mar 1997