CorRestore Patch System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040162 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vital Sync Model 5000 Series

  Class II

  FDA 510(k) K093422 Active Cleared 29 Apr 2010

• Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model Crps

  Class II

  FDA 510(k) K011487 Active Cleared 21 Nov 2001

• Somanetics Invos 3100A Cerebral Oximeter (Invos)

  Class II

  FDA 510(k) K960614 Active Cleared 5 Jun 1996

• Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-S

  Class II

  FDA 510(k) K091224 Active Cleared 9 Jul 2009

• Invos System

  Class II

  FDA 510(k) K051274 Active Cleared 4 Nov 2005

• Adult/Pediatric Cerebral Oximeter, Model Invos 5100

  Class II

  FDA 510(k) K001842 Active Cleared 15 Sep 2000

See all devices from Somanetics Corp. →

• What is the CorRestore Patch System primarily used for in surgical settings?

  The CorRestore Patch System is designed for intracardiac reconstruction and repair procedures, specifically to reinforce or replace damaged cardiac tissue during cardiovascular surgeries. Its oval shape and integrated suture bolster make it suitable for securing patches within the heart.

• Is the CorRestore Patch System intended for single-use or can it be reused?

  The CorRestore Patch System is explicitly labeled as a single-use device. While it is sterilized via glutaraldehyde fixation, it is not meant to be reprocessed or reused after a single surgical application, adhering to standard single-use medical device protocols.

• How is the CorRestore Patch System sterilized and what does that mean for handling?

  The patch is sterilized through glutaraldehyde fixation, which is a chemical process that eliminates microbial contamination. This means it is non-sterile in its original packaging and must be handled according to sterile surgical protocols before use, including proper terminal sterilization or aseptic techniques during surgery.

• What materials is the CorRestore Patch System made from and how does that affect its use?

  The CorRestore Patch System is composed of glutaraldehyde-fixed bovine pericardium, a durable biological tissue derived from cows. This material is biocompatible and designed for cardiac applications, but clinicians should be aware of potential considerations related to animal-derived materials, such as allergenic risks or religious restrictions.

• What regulatory pathway was followed for the CorRestore Patch System’s FDA clearance?

  The CorRestore Patch System underwent a traditional 510(k) review process and was determined to be *substantially equivalent* to a legally marketed predicate device. The clearance was granted by the FDA’s Cardiovascular (CV) Advisory Committee under the product code DXZ, confirming its classification as a Class II device under regulation 870.3470.