FDA 510(k)

ROVO Mechanical Thrombectomy Device

Numéro K : K220780 · 2023-03-31

Date de décision2023-03-31

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ROVO Mechanical Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is 2mg, Inc.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K220780. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ROVO Mechanical Thrombectomy Device?

ROVO Mechanical Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is 2mg, Inc.. The 510(k) number is K220780.

When did ROVO Mechanical Thrombectomy Device receive FDA 510(k) clearance?

ROVO Mechanical Thrombectomy Device received FDA 510(k) clearance on 2023-03-31, under 510(k) number K220780.

Who is the listed applicant for ROVO Mechanical Thrombectomy Device?

The FDA 510(k) record lists 2mg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROVO Mechanical Thrombectomy Device?

The FDA product code for ROVO Mechanical Thrombectomy Device is QEW.

Essais cliniques associés

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Dispositifs connexes (Code : QEW)

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Source officielle

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