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510(k) K973237

CSS-CARDIOPLEGIA SAFETY SYSTEM by Medtronic Bio-Medicus, Inc. — Product Code DWB

K973237 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "CSS-CARDIOPLEGIA SAFETY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 27, 1998. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1998
Date Received
August 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class
Class II
Regulation Number
870.4370
Review Panel
CV
Submission Type

Other clearances by Medtronic Bio-Medicus, Inc.

  • 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)
  • 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)

Other clearances for product code DWB

  • K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll (November 17, 2016)
  • K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER P (September 27, 2013)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • K960974 — COBE CENTURY PERFUSION PUMP (July 14, 1997)
  • K953901 — SARNS 800 ROLLER PUMP (April 19, 1996)
  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)
  • K890904 — MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (April 12, 1989)

FDA data resources