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FDA 510(k)

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC

K-Number: K093947 · 2010-01-21

Decision Date2010-01-21
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2010-01-21 under 510(k) number K093947. 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 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC?

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K093947.

When did ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC receive FDA 510(k) clearance?

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC received FDA 510(k) clearance on 2010-01-21, under 510(k) number K093947.

Who is the listed applicant for ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC?

The FDA product code for ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC 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 Merit Medical Systems, 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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