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510(k) K091626

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH by Cryolife, Inc. — Product Code DXZ

K091626 is an FDA 510(k) premarket notification submitted by Cryolife, Inc. for the device "CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), 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
August 7, 2009
Date Received
June 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Other clearances by Cryolife, Inc.

  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • 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)
  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)
  • K033484 — HUMAN HEART VALVE, CRYOVALVE SG (February 7, 2008)

Other clearances for product code DXZ

  • K240775 — PeriBeam® Pericardial Membrane (April 18, 2025)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (July 8, 2020)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K162579 — VascuCel (October 14, 2016)
  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (October 27, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)

FDA data resources