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FDA 510(k)

BARD BILIARY BALLOON DILATORS

K-Number: K920361 · 1992-11-24

Decision Date1992-11-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD BILIARY BALLOON DILATORS 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 1992-11-24 under 510(k) number K920361. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD BILIARY BALLOON DILATORS?

BARD BILIARY BALLOON DILATORS is a medical device that received FDA 510(k) clearance on 1992-11-24. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K920361.

When did BARD BILIARY BALLOON DILATORS receive FDA 510(k) clearance?

BARD BILIARY BALLOON DILATORS received FDA 510(k) clearance on 1992-11-24, under 510(k) number K920361.

Who is the listed applicant for BARD BILIARY BALLOON DILATORS?

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 BILIARY BALLOON DILATORS?

The FDA product code for BARD BILIARY BALLOON DILATORS is FGE.

Related Clinical Trials

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.

Other records listing C.R. Bard, Inc. as applicant

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.

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Related Devices (Code: FGE)

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.

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.

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