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FDA 510(k)

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE

K-Number: K043193 · 2004-12-07

ApplicantC.R. Bard, Inc.
Decision Date2004-12-07
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2004-12-07 under 510(k) number K043193. 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 BARD INLAYOPTIMA URETERAL STENT WITH SUTURE?

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE is a medical device that received FDA 510(k) clearance on 2004-12-07. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K043193.

When did BARD INLAYOPTIMA URETERAL STENT WITH SUTURE receive FDA 510(k) clearance?

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE received FDA 510(k) clearance on 2004-12-07, under 510(k) number K043193.

Who is the listed applicant for BARD INLAYOPTIMA URETERAL STENT WITH SUTURE?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD INLAYOPTIMA URETERAL STENT WITH SUTURE?

The FDA product code for BARD INLAYOPTIMA URETERAL STENT WITH SUTURE is FAD.

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Related Devices (Code: FAD)

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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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