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FDA 510(k)

UROMAX ULTRA BALLOON DILATATION CATHETER

K-Number: K130804 · 2013-05-22

ApplicantBoston Scientific Corporation
Decision Date2013-05-22
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROMAX ULTRA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2013-05-22 under 510(k) number K130804. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROMAX ULTRA BALLOON DILATATION CATHETER?

UROMAX ULTRA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-22. The listed applicant is Boston Scientific Corporation. The 510(k) number is K130804.

When did UROMAX ULTRA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

UROMAX ULTRA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2013-05-22, under 510(k) number K130804.

Who is the listed applicant for UROMAX ULTRA BALLOON DILATATION CATHETER?

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

What is the FDA product code for UROMAX ULTRA BALLOON DILATATION CATHETER?

The FDA product code for UROMAX ULTRA BALLOON DILATATION CATHETER 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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