Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters— 510(k) K171043

Name: FDA 510(k) clearance K171043
Creator: U.S. Food and Drug Administration
Published: 2017-12-21

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K171043 for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters, Substantially Equivalent on 2017-12-21. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-04-07
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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