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510(k) K973011

BPX80 BIO-PUMP (BPX80) by Medtronic Bio-Medicus, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
August 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Medtronic Bio-Medicus, Inc.

  • K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM (April 27, 1998)
  • K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (January 16, 1996)
  • K941922 — MEDSAT OXYGEN SATURATION SYSTEM (February 17, 1995)
  • K936091 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (December 23, 1994)
  • K941921 — BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (July 20, 1994)
  • K924208 — BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) (July 8, 1993)
  • K926357 — MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 (June 2, 1993)
  • K924206 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (May 7, 1993)
  • K924205 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (May 6, 1993)
  • K924642 — MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER (March 26, 1993)

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