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510(k) K081881

GISH TUBING AND CONNECTORS WITH HA COATING by Gish Biomedical, Inc. — Product Code DWF

K081881 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "GISH TUBING AND CONNECTORS WITH HA COATING". The FDA issued a decision of Substantially Equivalent on January 23, 2009. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
July 2, 2008
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 Gish Biomedical, Inc.

  • K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT (September 18, 2009)
  • K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT (September 18, 2009)
  • K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (August 4, 2009)
  • K083131 — MEDOS HILITE RESERVOIR, MODEL: 4030 (July 30, 2009)
  • K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT (May 15, 2009)
  • K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (February 4, 2009)
  • K082082 — GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (February 4, 2009)
  • K080708 — VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (February 2, 2009)
  • K081838 — GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (January 26, 2009)
  • K081054 — GISH ARTERIAL FILTER WITH HA COATING (January 15, 2009)

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