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FDA 510(k)

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM

K-Number: K991793 · 1999-06-25

Decision Date1999-06-25
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K991793. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM?

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K991793.

When did ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM receive FDA 510(k) clearance?

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991793.

Who is the listed applicant for ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM?

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

What is the FDA product code for ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM?

The FDA product code for ANGIODYNAMICS BALLOON EXPANDABLE 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 AngioDynamics, 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 82 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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