Cleared Traditional

K972201 - PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

K972201 is an FDA 510(k) clearance for PATCH, manufactured by Sulzer Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K972201 · Sulzer Carbomedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
307d
Days
Class 2
Risk

K972201 is an FDA 510(k) clearance for the PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Sulzer Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on April 14, 1998 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sulzer Carbomedics, Inc. devices

FDA 510(k) Submission Details - K972201

510(k) Number K972201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1997
Decision Date April 14, 1998
Days to Decision 307 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
182d slower than avg
Panel avg: 125d · This submission: 307d
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 55
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K972201.
CV PERI-GUARD AND VASCU-GUARD
K983602 · Bio-Vascular, Inc. · Nov 1998
SHELHIGH NO-REACT VASCUPATCH
K982810 · Shelhigh, Inc. · Oct 1998
SHELHIGH NO-REACT PERICARDIAL PATCHES
K974914 · Shelhigh, Inc. · Jun 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · Bio-Vascular, Inc. · Apr 1998
FLUORO-TEX SURGICAL MEMBRANE
K973178 · Bridger Biomed, Inc. · Nov 1997
SHELHIGH PERICARDIAL PATCH
K964467 · Shelhigh, Inc. · Sep 1997