COAXIAL DUAL FLOW CATHETER— 510(k) K820859

Name: FDA 510(k) clearance K820859
Creator: U.S. Food and Drug Administration
Published: 1982-04-16

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K820859 for COAXIAL DUAL FLOW CATHETER, Substantially Equivalent on 1982-04-16. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code LBW
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-03-29
Decision date: 1982-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.