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510(k) K992056

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 by Sulzer Carbomedics, Inc. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1999
Date Received
June 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
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)
  • K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (December 29, 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 KRH

  • K253232 — Seguin Annuloplasty Ring (October 29, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuFo (July 1, 2020)
  • K192762 — Physio Flex Annuloplasty Ring (December 16, 2019)