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510(k) K891687

EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE by Medtronic Blood Systems, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1989
Date Received
March 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
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)
  • K893678 — DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (November 27, 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)

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