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FDA 510(k)

ASCEND BALLOON DAILATION CATHETER

K-Number: K970041 · 1997-03-19

ApplicantCook Urological, Inc.
Decision Date1997-03-19
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASCEND BALLOON DAILATION CATHETER 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 1997-03-19 under 510(k) number K970041. 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 ASCEND BALLOON DAILATION CATHETER?

ASCEND BALLOON DAILATION CATHETER is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Cook Urological, Inc.. The 510(k) number is K970041.

When did ASCEND BALLOON DAILATION CATHETER receive FDA 510(k) clearance?

ASCEND BALLOON DAILATION CATHETER received FDA 510(k) clearance on 1997-03-19, under 510(k) number K970041.

Who is the listed applicant for ASCEND BALLOON DAILATION CATHETER?

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 ASCEND BALLOON DAILATION CATHETER?

The FDA product code for ASCEND BALLOON DAILATION CATHETER 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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