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510(k) K081054

GISH ARTERIAL FILTER WITH HA COATING by Gish Biomedical, Inc. — Product Code DTM

K081054 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "GISH ARTERIAL FILTER WITH HA COATING". The FDA issued a decision of Substantially Equivalent on January 15, 2009. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2009
Date Received
April 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
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)
  • K081881 — GISH TUBING AND CONNECTORS WITH HA COATING (January 23, 2009)

Other clearances for product code DTM

  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K242953 — KIDS Arterial Filters (December 20, 2024)
  • K242092 — MICRO Arterial Filters (November 18, 2024)
  • K231362 — OCS Heart Leukocyte Depleting Filter (October 31, 2023)
  • K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (March 19, 2013)
  • K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 7, 2012)
  • K121209 — TERUMO PALL AL20X ARTERIAL FILTER (May 8, 2012)
  • K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (September 29, 2011)
  • K100646 — AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (December 16, 2010)
  • K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (January 22, 2010)

FDA data resources