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FDA 510(k)

MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER

K-Number: K902370 · 1990-08-17

ApplicantBoston Scientific Corp
Decision Date1990-08-17
Product CodeFAH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K902370. The device is classified under product code FAH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER?

MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Boston Scientific Corp. The 510(k) number is K902370.

When did MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER receive FDA 510(k) clearance?

MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER received FDA 510(k) clearance on 1990-08-17, under 510(k) number K902370.

Who is the listed applicant for MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER?

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

What is the FDA product code for MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER?

The FDA product code for MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER is FAH.

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Related Devices (Code: FAH)

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.

K933957DILATING URETHRAL SOUNDCook Urological, Inc.K902124DOWD CATHETERBoston Scientific CorpK831384COAXIAL BALLOON URETHRAL DILATORThomas J. Fogarty, M.D.

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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