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FDA 510(k)

PROTEGE GPS SELF-EXPANDING NITINOL STENT

K-Number: K050725 · 2005-04-20

Decision Date2005-04-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROTEGE GPS SELF-EXPANDING NITINOL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Corporation. It received FDA 510(k) clearance on 2005-04-20 under 510(k) number K050725. 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 PROTEGE GPS SELF-EXPANDING NITINOL STENT?

PROTEGE GPS SELF-EXPANDING NITINOL STENT is a medical device that received FDA 510(k) clearance on 2005-04-20. The listed applicant is Ev3 Corporation. The 510(k) number is K050725.

When did PROTEGE GPS SELF-EXPANDING NITINOL STENT receive FDA 510(k) clearance?

PROTEGE GPS SELF-EXPANDING NITINOL STENT received FDA 510(k) clearance on 2005-04-20, under 510(k) number K050725.

Who is the listed applicant for PROTEGE GPS SELF-EXPANDING NITINOL STENT?

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

What is the FDA product code for PROTEGE GPS SELF-EXPANDING NITINOL STENT?

The FDA product code for PROTEGE GPS SELF-EXPANDING NITINOL STENT 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 Ev3 Corporation 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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