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FDA 510(k)

OMNILINK .018 BILIARY STENT SYSTEM

K-Number: K033834 · 2004-01-02

ApplicantGuidant Corp.
Decision Date2004-01-02
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

OMNILINK .018 BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2004-01-02 under 510(k) number K033834. 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 OMNILINK .018 BILIARY STENT SYSTEM?

OMNILINK .018 BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-02. The listed applicant is Guidant Corp.. The 510(k) number is K033834.

When did OMNILINK .018 BILIARY STENT SYSTEM receive FDA 510(k) clearance?

OMNILINK .018 BILIARY STENT SYSTEM received FDA 510(k) clearance on 2004-01-02, under 510(k) number K033834.

Who is the listed applicant for OMNILINK .018 BILIARY STENT SYSTEM?

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

What is the FDA product code for OMNILINK .018 BILIARY STENT SYSTEM?

The FDA product code for OMNILINK .018 BILIARY STENT SYSTEM 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 Guidant Corp. 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 71 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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