HURWITZ DIALYSIS CATHETER— 510(k) K860094

Name: FDA 510(k) clearance K860094
Creator: U.S. Food and Drug Administration
Published: 1986-04-07

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K860094 for HURWITZ DIALYSIS CATHETER, Substantially Equivalent on 1986-04-07. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1986-01-10
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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