Cleared Traditional

K974914 - SHELHIGH NO-REACT PERICARDIAL PATCHES

K974914 is an FDA 510(k) clearance for SHELHIGH NO-REACT PERICARDIAL PATCHES, manufactured by Shelhigh, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K974914 · Shelhigh, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
177d
Days
Class 2
Risk

K974914 is an FDA 510(k) clearance for the SHELHIGH NO-REACT PERICARDIAL PATCHES. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Shelhigh, Inc. (Millburn, US). The FDA issued a Cleared decision on June 3, 1998 after a review of 177 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 Shelhigh, Inc. devices

FDA 510(k) Submission Details - K974914

510(k) Number K974914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date June 03, 1998
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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 K974914.
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
CV PERI-GUARD AND VASCU-GUARD
K983602 · Bio-Vascular, Inc. · Nov 1998
SHELHIGH NO-REACT VASCUPATCH
K982810 · Shelhigh, Inc. · Oct 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201 · Sulzer Carbomedics, Inc. · Apr 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · Bio-Vascular, Inc. · Apr 1998
FLUORO-TEX SURGICAL MEMBRANE
K973178 · Bridger Biomed, Inc. · Nov 1997