Cleared Traditional

K011487 - CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4

Also marketed or referenced as:
CORRESTORE SIZER, MODEL CRPS

K011487 is an FDA 510(k) clearance for CORRESTORE PATCH, manufactured by Somanetics Corp.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K011487 · Somanetics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
190d
Days
Class 2
Risk

K011487 is an FDA 510(k) clearance for the CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Somanetics Corp. (Troy, US). The FDA issued a Cleared decision on November 21, 2001 after a review of 190 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 Somanetics Corp. devices

FDA 510(k) Submission Details - K011487

510(k) Number K011487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date November 21, 2001
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
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 K011487.
CHARE CARIOVASCULAR PATCH
K021129 · Chase Medical, Inc. · Jun 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233 · Chase Medical, Inc. · Mar 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · Chase Medical, Inc. · Feb 2002
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