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510(k) K970375

ANNULOFLO SYSTEM by Carbomedics, Inc. — Product Code KRH

Clearance Details

Decision
ST ()
Decision Date
July 25, 1997
Date Received
February 3, 1997
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 Carbomedics, Inc.

  • K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (February 19, 1997)
  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)
  • K960706 — VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT (April 25, 1996)
  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K955588 — VASCUTEK GRAFT SIZER SET (March 7, 1996)
  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)
  • K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (July 6, 1994)
  • K934951 — VALVE SIZER (December 10, 1993)

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)