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FDA 510(k)

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05

K-Number: K072301 · 2008-03-18

ApplicantEv3, Inc.
Decision Date2008-03-18
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2008-03-18 under 510(k) number K072301. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05?

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 is a medical device that received FDA 510(k) clearance on 2008-03-18. The listed applicant is Ev3, Inc.. The 510(k) number is K072301.

When did 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 receive FDA 510(k) clearance?

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 received FDA 510(k) clearance on 2008-03-18, under 510(k) number K072301.

Who is the listed applicant for 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05?

The FDA 510(k) record lists Ev3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05?

The FDA product code for 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 is FGE.

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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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