Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter— 510(k) K182695

Name: FDA 510(k) clearance K182695
Creator: U.S. Food and Drug Administration
Published: 2019-06-17

Unknown

Cook Incorporated

FDA 510(k) clearance K182695 for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter, Unknown on 2019-06-17. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-27
Decision date: 2019-06-17
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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