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510(k) K780410

BLOOD PUMP-MODE S10K by 3M Health Care, Sarns — Product Code FIR

K780410 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "BLOOD PUMP-MODE S10K". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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 FIR

  • K961137 — ATI PLASMA PUMP (PP-04) (June 14, 1996)
  • K831953 — INFUSION PUMP (July 19, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)
  • K821139 — SPS-SINGLE PATIENT SYSTEM (May 10, 1982)
  • K771705 — RS-7800 MINIPUMP (October 4, 1977)
  • K761050 — HEPARIN PUMP (December 30, 1976)

FDA data resources