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510(k) K950739

3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM by 3M Health Care, Sarns — Product Code DWA

K950739 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 17, 1995. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1995
Date Received
February 17, 1995
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 3M Health Care, Sarns

  • K960916 — SAMS 8000 CARDIOPLEGIA MONITOR (June 4, 1996)
  • K953901 — SARNS 800 ROLLER PUMP (April 19, 1996)
  • K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION (August 24, 1994)
  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934127 — SARNS LOW JETTING AORTIC ARCH CANNULA (February 22, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K915547 — SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT (September 9, 1993)
  • K925075 — SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR (June 7, 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