FDA 510(k)

Système d'oxygénateur Fusion Affinity, Système d'oxygénation Pixie Affinity

Numéro K : K203111 · 2021-09-16

Date de décision2021-09-16

Code produitDTZ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K203111. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Medtronic. The 510(k) number is K203111.

When did Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System receive FDA 510(k) clearance?

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System received FDA 510(k) clearance on 2021-09-16, under 510(k) number K203111.

Who is the listed applicant for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?

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

What is the FDA product code for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?

The FDA product code for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is DTZ.

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Source officielle

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