FDA 510(k)

Kalera Vacuum Aspiration Catheter (K-VAC)

Номер K: K200419 · 2020-05-22

Дата решения2020-05-22

Код продуктаFED

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Kalera Vacuum Aspiration Catheter (K-VAC) is the device name listed in this FDA 510(k) record. The listed applicant is Kalera Medical, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K200419. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Kalera Vacuum Aspiration Catheter (K-VAC)?

Kalera Vacuum Aspiration Catheter (K-VAC) is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Kalera Medical, Inc.. The 510(k) number is K200419.

When did Kalera Vacuum Aspiration Catheter (K-VAC) receive FDA 510(k) clearance?

Kalera Vacuum Aspiration Catheter (K-VAC) received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200419.

Who is the listed applicant for Kalera Vacuum Aspiration Catheter (K-VAC)?

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

What is the FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC)?

The FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC) is FED.

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: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Официальный источник

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