FDA 510(k)

MODIFIED URETERAL INDWELLING CATHETER/STENT

K-Number: K974541 · 1998-02-09

Decision Date1998-02-09

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODIFIED URETERAL INDWELLING CATHETER/STENT 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 1998-02-09 under 510(k) number K974541. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED URETERAL INDWELLING CATHETER/STENT?

MODIFIED URETERAL INDWELLING CATHETER/STENT is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Boston Scientific Corp. The 510(k) number is K974541.

When did MODIFIED URETERAL INDWELLING CATHETER/STENT receive FDA 510(k) clearance?

MODIFIED URETERAL INDWELLING CATHETER/STENT received FDA 510(k) clearance on 1998-02-09, under 510(k) number K974541.

Who is the listed applicant for MODIFIED URETERAL INDWELLING CATHETER/STENT?

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 URETERAL INDWELLING CATHETER/STENT?

The FDA product code for MODIFIED URETERAL INDWELLING CATHETER/STENT is FAD.

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Related Devices (Code: FAD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.