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510(k) K925442

SARNS RETROGRADE CANNULA by 3M Health Care, Sarns — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1993
Date Received
October 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
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 DWF

  • K250937 — Venous Return Cannulae (March 11, 2026)
  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (February 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)