FDA 510(k)

Medtronic Confida Brecker Guidewire

Numéro K : K181001 · 2018-05-03

Date de décision2018-05-03

Code produitDQX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Medtronic Confida Brecker Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Core Valve, LLC. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K181001. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Medtronic Confida Brecker Guidewire?

Medtronic Confida Brecker Guidewire is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Medtronic Core Valve, LLC. The 510(k) number is K181001.

When did Medtronic Confida Brecker Guidewire receive FDA 510(k) clearance?

Medtronic Confida Brecker Guidewire received FDA 510(k) clearance on 2018-05-03, under 510(k) number K181001.

Who is the listed applicant for Medtronic Confida Brecker Guidewire?

The FDA 510(k) record lists Medtronic Core Valve, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Confida Brecker Guidewire?

The FDA product code for Medtronic Confida Brecker Guidewire is DQX.

Essais cliniques associés

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Dispositifs connexes (Code : DQX)

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Source officielle

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