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FDA 510(k)

UPJ Occlusion Balloon Catheter

K-Number: K183323 · 2019-08-05

ApplicantCook Incorporated
Decision Date2019-08-05
Product CodeEYB
Advisory CommitteeGU
DecisionUnknown

Device Summary

UPJ Occlusion Balloon Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-08-05 under approval number K183323. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the UPJ Occlusion Balloon Catheter?

UPJ Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Cook Incorporated. The 510(k) number is K183323.

When was UPJ Occlusion Balloon Catheter approved by the FDA?

UPJ Occlusion Balloon Catheter received FDA 510(k) clearance on 2019-08-05, under approval number K183323.

What company makes UPJ Occlusion Balloon Catheter?

UPJ Occlusion Balloon Catheter is manufactured by Cook Incorporated.

What is the FDA product code for UPJ Occlusion Balloon Catheter?

The FDA product code for UPJ Occlusion Balloon Catheter is EYB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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