SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA— 510(k) K861174

Name: FDA 510(k) clearance K861174
Creator: U.S. Food and Drug Administration
Published: 1986-04-23

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K861174 for SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA, Substantially Equivalent on 1986-04-23. 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: 1986-03-25
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.