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FDA 510(k)

ENTRAC URETHRAL BALLOON DILATATION CATHETER

K-Number: K920711 · 1992-05-06

ApplicantAmerican Medical Systems, Inc.
Decision Date1992-05-06
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTRAC URETHRAL BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-05-06 under 510(k) number K920711. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTRAC URETHRAL BALLOON DILATATION CATHETER?

ENTRAC URETHRAL BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1992-05-06. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K920711.

When did ENTRAC URETHRAL BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

ENTRAC URETHRAL BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1992-05-06, under 510(k) number K920711.

Who is the listed applicant for ENTRAC URETHRAL BALLOON DILATATION CATHETER?

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

What is the FDA product code for ENTRAC URETHRAL BALLOON DILATATION CATHETER?

The FDA product code for ENTRAC URETHRAL BALLOON DILATATION CATHETER is KOE.

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Other records listing American Medical Systems, Inc. as applicant

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Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical 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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