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FDA 510(k)

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

K-Number: K050534 · 2005-05-20

Decision Date2005-05-20
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2005-05-20 under 510(k) number K050534. 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 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM?

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-20. The listed applicant is Abbott Laboratories. The 510(k) number is K050534.

When did XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM receive FDA 510(k) clearance?

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM received FDA 510(k) clearance on 2005-05-20, under 510(k) number K050534.

Who is the listed applicant for XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM?

The FDA product code for XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM is FGE.

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Other records listing Abbott Laboratories 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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