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510(k) K152127

CorMatrix Tyke by Cormatrix Cardiovascular, Inc. — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2016
Date Received
July 31, 2015
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 Cormatrix Cardiovascular, Inc.

  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K140306 — CORMATRIX PROTECT ECM ENVELOPE (August 15, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K111187 — PATCH, PLEDGET AND INTRACARDIAC (July 26, 2011)
  • K063349 — CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR (February 16, 2007)
  • K051405 — REGENSIS PERICARDIAL PATCH (August 31, 2005)

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)
  • 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)
  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)