FDA 510(k)

V.A.C.ULTA Negative Pressure Wound Therapy System

Номер K: K203316 · 2021-10-27

ЗаявительKci, A Part of 3M Health Care Business Group

Дата решения2021-10-27

Код продуктаOMP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

V.A.C.ULTA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Kci, A Part of 3M Health Care Business Group. It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K203316. 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 V.A.C.ULTA Negative Pressure Wound Therapy System?

V.A.C.ULTA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Kci, A Part of 3M Health Care Business Group. The 510(k) number is K203316.

When did V.A.C.ULTA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2021-10-27, under 510(k) number K203316.

Who is the listed applicant for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Kci, A Part of 3M Health Care Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA product code for V.A.C.ULTA 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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