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510(k) K022022

JOSTRA VENT CATHETERS, MODELS LV & HKV by Jostra AG — Product Code DWF

K022022 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "JOSTRA VENT CATHETERS, MODELS LV & HKV". The FDA issued a decision of Substantially Equivalent on September 11, 2002. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Jostra AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2002
Date Received
June 20, 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

  • K020983 — JOSTRA SUCKERS, MODEL JS (January 30, 2004)
  • 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)
  • 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)

Other clearances for product code DWF

  • K260195 — Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (April 23, 2026)
  • 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)

FDA data resources