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FDA 510(k)

COOK URETERAL BALLOON DILATION CATHETER SET

K-Number: K040127 · 2004-04-06

ApplicantCook Urological, Inc.
Decision Date2004-04-06
Product CodeEZN
Advisory CommitteeGU
DecisionUnknown

Device Summary

COOK URETERAL BALLOON DILATION CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2004-04-06 under 510(k) number K040127. 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 COOK URETERAL BALLOON DILATION CATHETER SET?

COOK URETERAL BALLOON DILATION CATHETER SET is a medical device that received FDA 510(k) clearance on 2004-04-06. The listed applicant is Cook Urological, Inc.. The 510(k) number is K040127.

When did COOK URETERAL BALLOON DILATION CATHETER SET receive FDA 510(k) clearance?

COOK URETERAL BALLOON DILATION CATHETER SET received FDA 510(k) clearance on 2004-04-06, under 510(k) number K040127.

Who is the listed applicant for COOK URETERAL BALLOON DILATION CATHETER SET?

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

What is the FDA product code for COOK URETERAL BALLOON DILATION CATHETER SET?

The FDA product code for COOK URETERAL BALLOON DILATION CATHETER SET is EZN.

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Other records listing Cook Urological, Inc. as applicant

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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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