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FDA 510(k)

BARD E LUMINEXX BILIARY STENT

K-Number: K063532 · 2008-05-30

Decision Date2008-05-30
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

BARD E LUMINEXX BILIARY STENT is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K063532. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BARD E LUMINEXX BILIARY STENT?

BARD E LUMINEXX BILIARY STENT is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K063532.

When did BARD E LUMINEXX BILIARY STENT receive FDA 510(k) clearance?

BARD E LUMINEXX BILIARY STENT received FDA 510(k) clearance on 2008-05-30, under 510(k) number K063532.

Who is the listed applicant for BARD E LUMINEXX BILIARY STENT?

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

What is the FDA product code for BARD E LUMINEXX BILIARY STENT?

The FDA product code for BARD E LUMINEXX BILIARY STENT 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 Bard Peripheral Vascular, 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.

View all 33 devices →

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

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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