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510(k) K972201

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE by Sulzer Carbomedics, Inc. — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1998
Date Received
June 11, 1997
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 Sulzer Carbomedics, Inc.

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  • K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (June 13, 2002)
  • K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR700 (April 23, 2002)
  • K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (January 25, 2001)
  • K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (December 29, 1999)
  • K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (October 12, 1999)
  • K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (August 4, 1998)

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  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (October 27, 2015)
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  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)