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FDA 510(k)

Balloon Catheter and Balloon Ureteral Dilator Set

K-Number: K172588 · 2018-04-19

ApplicantCook Incorporated
Decision Date2018-04-19
Product CodeEZN
Advisory CommitteeGU
DecisionUnknown

Device Summary

Balloon Catheter and Balloon Ureteral Dilator Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-19 under approval number K172588. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Balloon Catheter and Balloon Ureteral Dilator Set?

Balloon Catheter and Balloon Ureteral Dilator Set is a medical device that received FDA 510(k) clearance on 2018-04-19. It is manufactured by Cook Incorporated. The 510(k) number is K172588.

When was Balloon Catheter and Balloon Ureteral Dilator Set approved by the FDA?

Balloon Catheter and Balloon Ureteral Dilator Set received FDA 510(k) clearance on 2018-04-19, under approval number K172588.

What company makes Balloon Catheter and Balloon Ureteral Dilator Set?

Balloon Catheter and Balloon Ureteral Dilator Set is manufactured by Cook Incorporated.

What is the FDA product code for Balloon Catheter and Balloon Ureteral Dilator Set?

The FDA product code for Balloon Catheter and Balloon Ureteral Dilator Set is EZN.

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Related Devices (Code: EZN)

K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated K180756Safety Wire Guide IntroducerCook Incorporated K180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.

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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