GISH ARTERIAL FILTER WITH HA COATING— 510(k) K081054

Name: FDA 510(k) clearance K081054
Creator: U.S. Food and Drug Administration
Published: 2009-01-15

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K081054 for GISH ARTERIAL FILTER WITH HA COATING, Substantially Equivalent on 2009-01-15. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2008-04-14
Decision date: 2009-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTM

view all

K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
K242953 — KIDS Arterial Filters2024-12-20
K242092 — MICRO Arterial Filters2024-11-18
K231362 — OCS Heart Leukocyte Depleting Filter2023-10-31
K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2013-03-19

More clearances from Gish Biomedical, Inc.

view all

K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT2009-09-18
K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT2009-09-18
K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 07302009-08-04
K083131 — MEDOS HILITE RESERVOIR, MODEL: 40302009-07-30
K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT2009-05-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.