OTW MEGALINK SDS BILIARY STENT SYSTEM
K-Number: K000550 · 2000-03-17
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Device Summary
Frequently Asked Questions
What is the OTW MEGALINK SDS BILIARY STENT SYSTEM?
OTW MEGALINK SDS BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-17. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K000550.
When did OTW MEGALINK SDS BILIARY STENT SYSTEM receive FDA 510(k) clearance?
OTW MEGALINK SDS BILIARY STENT SYSTEM received FDA 510(k) clearance on 2000-03-17, under 510(k) number K000550.
Who is the listed applicant for OTW MEGALINK SDS BILIARY STENT SYSTEM?
The FDA 510(k) record lists Advanced Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OTW MEGALINK SDS BILIARY STENT SYSTEM?
The FDA product code for OTW MEGALINK SDS 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 Advanced Cardiovascular 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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