Home / 510(k) Clearances / K183635

510(k) K183635

PhotoFix Decellularized Bovine Pericardium by Cryolife, Inc. — Product Code PSQ

K183635 is an FDA 510(k) premarket notification submitted by Cryolife, Inc. for the device "PhotoFix Decellularized Bovine Pericardium". The FDA issued a decision of Substantially Equivalent on February 14, 2019. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Cryolife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2019
Date Received
December 26, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Other clearances by Cryolife, Inc.

  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K132105 — PERCLOT TOPICAL (April 3, 2014)
  • K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX (January 10, 2012)
  • K101587 — PROPATCH SOFT TISSUE REPAIR MATRIX (September 16, 2010)
  • K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (July 23, 2010)
  • K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (May 25, 2010)
  • K091626 — CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH (August 7, 2009)
  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)
  • K033484 — HUMAN HEART VALVE, CRYOVALVE SG (February 7, 2008)

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)
  • K170951 — CardioCel 3D (April 28, 2017)

FDA data resources