FDA 510(k)

extriCARE 1000 Negative Pressure Wound Therapy System

Номер K: K213906 · 2023-03-08

Дата решения2023-03-08

Код продуктаOMP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

extriCARE 1000 Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Alleva Medical, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K213906. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the extriCARE 1000 Negative Pressure Wound Therapy System?

extriCARE 1000 Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Alleva Medical, Ltd.. The 510(k) number is K213906.

When did extriCARE 1000 Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

extriCARE 1000 Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2023-03-08, under 510(k) number K213906.

Who is the listed applicant for extriCARE 1000 Negative Pressure Wound Therapy System?

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

What is the FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System?

The FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System is OMP.

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.

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Связанные устройства (Код: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Официальный источник

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