FDA 510(k)

WOLF Thrombectomy Device

Numéro K : K182835 · 2019-03-27

Date de décision2019-03-27

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

WOLF Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is 880 Medical, LLC. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K182835. 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 WOLF Thrombectomy Device?

WOLF Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is 880 Medical, LLC. The 510(k) number is K182835.

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

WOLF Thrombectomy Device received FDA 510(k) clearance on 2019-03-27, under 510(k) number K182835.

Who is the listed applicant for WOLF Thrombectomy Device?

The FDA 510(k) record lists 880 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOLF Thrombectomy Device?

The FDA product code for WOLF 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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