UPJ Occlusion Balloon Catheter— 510(k) K183323

Unknown

Cook Incorporated

FDA 510(k) clearance K183323 for UPJ Occlusion Balloon Catheter, Unknown on 2019-08-05. 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: 2018-11-30
Decision date: 2019-08-05
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, 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.