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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-08-05 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K183323.

When did UPJ Occlusion Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for UPJ Occlusion Balloon Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06798753Occlusion Balloon vs. 5FR Ureteral CatheterCOMPLETEDNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

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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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