FLEXIBLE INTRACARDIAC SUCTION DEVICE— 510(k) K905008

Name: FDA 510(k) clearance K905008
Creator: U.S. Food and Drug Administration
Published: 1991-01-23

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K905008 for FLEXIBLE INTRACARDIAC SUCTION DEVICE, Substantially Equivalent on 1991-01-23. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTS
Device class: Class 2
Regulation: 21 CFR 870.4420
Advisory panel: Cardiovascular
Date received: 1990-11-06
Decision date: 1991-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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