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510(k) K915183

SARNS 8000 MODULAR PERFUSION SYSTEM by 3M Health Care, Sarns — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
November 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
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 DTQ

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)