MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K-Number: K013737 · 2002-03-01
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Device Summary
Frequently Asked Questions
What is the MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON?
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON is a medical device that received FDA 510(k) clearance on 2002-03-01. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K013737.
When did MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON receive FDA 510(k) clearance?
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON received FDA 510(k) clearance on 2002-03-01, under 510(k) number K013737.
Who is the listed applicant for MODIFICATION TO: 3-LUMEN DURALON 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 MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON?
The FDA product code for MODIFICATION TO: 3-LUMEN DURALON 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.
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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