FDA 510(k)

ROVO Mechanical Thrombectomy Device

Номер K: K220780 · 2023-03-31

Заявитель2mg, Inc.

Дата решения2023-03-31

Код продуктаQEW

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: QEW)

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.