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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-04-19 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K172588.

When did Balloon Catheter and Balloon Ureteral Dilator Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Balloon Catheter and Balloon Ureteral Dilator Set?

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 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)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook Incorporated

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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