FDA 510(k)

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

Номер K: K161967 · 2017-01-27

Дата решения2017-01-27

Код продуктаKRA

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is the device name listed in this FDA 510(k) record. The listed applicant is Callisyn Biomedical, Inc.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K161967. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Callisyn Biomedical, Inc.. The 510(k) number is K161967.

When did FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm receive FDA 510(k) clearance?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161967.

Who is the listed applicant for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

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

What is the FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

The FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is KRA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: KRA)

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences K254051Система инфузионного катетера для введенияSmartWise Sweden AB K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K250794InVera Infusion DeviceInvera Medical K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.