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510(k) K020983

JOSTRA SUCKERS, MODEL JS by Jostra AG — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
March 27, 2002
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 Jostra AG

  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)
  • K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (February 26, 2003)
  • K020784 — JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (January 9, 2003)
  • K023132 — JOSTRA MECC SYSTEM (December 17, 2002)
  • K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV (September 11, 2002)
  • K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (April 24, 2002)
  • K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
  • K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
  • K013939 — JOSTRA FLOWPROBE FP-32E (December 14, 2001)
  • K012774 — JOSTRA ARTERIAL PERFUSION CANNULAE (November 16, 2001)

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  • 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)
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  • 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)