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510(k) K781145

MONITOR KITS, BLOOD LEVEL by 3M Health Care, Sarns — Product Code DTW

K781145 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "MONITOR KITS, BLOOD LEVEL". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
July 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
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)
  • K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTE (November 17, 1995)
  • 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)

Other clearances for product code DTW

  • K150530 — Level Sensor, Level Sensor Tape (May 8, 2015)
  • K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM (July 2, 2004)
  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (May 20, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
  • K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (May 22, 1990)
  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)

FDA data resources