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FDA 510(k)

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON

K-Number: K901427 · 1990-06-22

Decision Date1990-06-22
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 1990-06-22 under 510(k) number K901427. 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 BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON?

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K901427.

When did BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON receive FDA 510(k) clearance?

BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON received FDA 510(k) clearance on 1990-06-22, under 510(k) number K901427.

Who is the listed applicant for BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON?

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

What is the FDA product code for BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON?

The FDA product code for BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON 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 Telemed 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.

View all 22 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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