FDA 510(k)

Système Acutrak d'Acumed - Conditionnel à l'IRM, Système Acutrak 2 d'Acumed - Conditionnel à l'IRM

Numéro K : K221333 · 2022-12-29

Date de décision2022-12-29

Code produitHWC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221333. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Acumed, LLC. The 510(k) number is K221333.

When did Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional receive FDA 510(k) clearance?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221333.

Who is the listed applicant for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

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

What is the FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

The FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is HWC. This falls under the Cardiovascular category.

Essais cliniques associés

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Autres dossiers indiquant Acumed, LLC en tant que demandeur

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Source officielle

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