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510(k) K893678

DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H by Medtronic Blood Systems, Inc. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1989
Date Received
May 16, 1989
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 Medtronic Blood Systems, Inc.

  • K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 (July 14, 1995)
  • K944957 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 (July 14, 1995)
  • K893207 — CLOSED CHEST SUPPORT CIRCUIT (December 12, 1989)
  • K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (May 31, 1989)
  • K891230 — MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. (May 19, 1989)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883439 — INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (October 13, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)

Other clearances for product code KRH

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  • 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)