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510(k) K140306

CORMATRIX PROTECT ECM ENVELOPE by Cormatrix Cardiovascular, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2014
Date Received
February 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
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)
  • K152127 — CorMatrix Tyke (February 4, 2016)
  • 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)

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