Cleared Traditional

K001785 - SURGISIS PERIPHERAL VASCULAR PATCH

K001785 is an FDA 510(k) clearance for SURGISIS PERIPHERAL VASCULAR PATCH, manufactured by Cook Biotech, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K001785 · Cook Biotech, Inc. · Cardiovascular device
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Dec 2000
Decision
197d
Days
Class 2
Risk

K001785 is an FDA 510(k) clearance for the SURGISIS PERIPHERAL VASCULAR PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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 Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K001785

510(k) Number K001785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2000
Decision Date December 27, 2000
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 74
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K001785.
PRECLUDE PERICARDIAL MEMBRANE
K012098 · W.L. Gore & Associates, Inc. · Sep 2001
CHASE CARDIOVASCULAR PATCH
K012248 · Chase Medical, Inc. · Aug 2001
CHASE CARDIOVASCULAR PATCH
K003467 · Chase Medical, Inc. · Jan 2001
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
CHASE CARDIOVASCULAR PATCH
K001662 · Chase Medical, Inc. · Aug 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · Bridger Biomed, Inc. · Jul 2000