GISH ARTERIAL FILTER— 510(k) K914791

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K914791 for GISH ARTERIAL FILTER, Substantially Equivalent on 1993-04-06. 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: 1991-10-23
Decision date: 1993-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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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.