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FDA 510(k)

LIFESTENT TURBO BILIARY STENT SYSTEMS

K-Number: K050627 · 2005-03-22

Decision Date2005-03-22
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

LIFESTENT TURBO BILIARY STENT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2005-03-22 under 510(k) number K050627. 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 LIFESTENT TURBO BILIARY STENT SYSTEMS?

LIFESTENT TURBO BILIARY STENT SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K050627.

When did LIFESTENT TURBO BILIARY STENT SYSTEMS receive FDA 510(k) clearance?

LIFESTENT TURBO BILIARY STENT SYSTEMS received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050627.

Who is the listed applicant for LIFESTENT TURBO BILIARY STENT SYSTEMS?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESTENT TURBO BILIARY STENT SYSTEMS?

The FDA product code for LIFESTENT TURBO BILIARY STENT SYSTEMS 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 Edwards Lifesciences, LLC 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 122 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

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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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