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510(k) K993288

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM by Sulzer Carbomedics, Inc. — Product Code DXZ

K993288 is an FDA 510(k) premarket notification submitted by Sulzer Carbomedics, Inc. for the device "SULZER CARBOMEDICS CARDIOFIX PERICARDIUM". The FDA issued a decision of Substantially Equivalent on December 29, 1999. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Sulzer Carbomedics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1999
Date Received
October 1, 1999
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.

  • K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (December 17, 2002)
  • 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)
  • K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (October 12, 1999)
  • K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (August 4, 1998)
  • K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (April 14, 1998)

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