Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
K-Number: K163169 · 2017-02-07
Device Summary
Frequently Asked Questions
What is the Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163169.
When did Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent receive FDA 510(k) clearance?
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent received FDA 510(k) clearance on 2017-02-07, under 510(k) number K163169.
Who is the listed applicant for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
The FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is FGE.
Other records listing Cook Ireland, Ltd. 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
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