FDA 510(k)

LotusCatheter (Lotus No Balloon Catheter)

Номер K: K191512 · 2020-05-21

ЗаявительHakki Medical Technologies, Inc.

Дата решения2020-05-21

Код продуктаGBM

Консультативный комитетGU

РешениеUnknown

Описание устройства

LotusCatheter (Lotus No Balloon Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Часто задаваемые вопросы

What is the LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K191512.

When did LotusCatheter (Lotus No Balloon Catheter) receive FDA 510(k) clearance?

LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K191512.

Who is the listed applicant for LotusCatheter (Lotus No Balloon Catheter)?

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

What is the FDA product code for LotusCatheter (Lotus No Balloon Catheter)?

The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.

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: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

Официальный источник

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