SHIELY DUEL LUMEN SUBCLAVIAN CANNULA— 510(k) K822134

Name: FDA 510(k) clearance K822134
Creator: U.S. Food and Drug Administration
Published: 1982-08-03

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K822134 for SHIELY DUEL LUMEN SUBCLAVIAN CANNULA, Substantially Equivalent on 1982-08-03. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-07-20
Decision date: 1982-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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