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510(k) K924206

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E by Medtronic Bio-Medicus, Inc. — Product Code DWA

K924206 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E". The FDA issued a decision of Substantially Equivalent on May 7, 1993. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1993
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

Other clearances by Medtronic Bio-Medicus, Inc.

  • K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM (April 27, 1998)
  • K973011 — BPX80 BIO-PUMP (BPX80) (February 25, 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)
  • K924205 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (May 6, 1993)
  • K924642 — MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER (March 26, 1993)

Other clearances for product code DWA

  • K232788 — INSPIRA ART100 (May 24, 2024)
  • K230698 — Anivia SG1000 Pump Console (April 18, 2023)
  • K221491 — Anivia SG1000 Pump Console (February 3, 2023)
  • K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pre (April 13, 2020)
  • K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, C (March 6, 2020)
  • K191557 — CentriMag Acute Circulatory Support System (July 10, 2019)
  • K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (July 24, 2013)
  • K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (July 18, 2013)
  • K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5) (September 20, 2011)
  • K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (January 20, 2011)

FDA data resources