FDA 510(k)

13G InterV Kyphoplasty Catheter (Микро) и 11G InterV Kyphoplasty Catheter (Mini-Flex)

Номер K: K162453 · 2016-11-01

Дата решения2016-11-01

Код продуктаNDN

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is Pan Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162453. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Pan Medical , Ltd.. The 510(k) number is K162453.

When did 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) receive FDA 510(k) clearance?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162453.

Who is the listed applicant for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

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

What is the FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

The FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is NDN.

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: NDN)

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Официальный источник

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