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FDA 510(k)

PRIMUS GPS BILIARY STENT SYSTEM

K-Number: K061566 · 2006-08-31

ApplicantEv3, Inc.
Decision Date2006-08-31
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

PRIMUS GPS BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2006-08-31 under 510(k) number K061566. 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 PRIMUS GPS BILIARY STENT SYSTEM?

PRIMUS GPS BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Ev3, Inc.. The 510(k) number is K061566.

When did PRIMUS GPS BILIARY STENT SYSTEM receive FDA 510(k) clearance?

PRIMUS GPS BILIARY STENT SYSTEM received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061566.

Who is the listed applicant for PRIMUS GPS BILIARY STENT SYSTEM?

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 PRIMUS GPS BILIARY STENT SYSTEM?

The FDA product code for PRIMUS GPS 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 Ev3, 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.

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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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