FDA 510(k)

BESPA Charcot System

Номер K: K202326 · 2021-11-09

Дата решения2021-11-09

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

BESPA Charcot System is the device name listed in this FDA 510(k) record. The listed applicant is Bespa Global, LLC. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K202326. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BESPA Charcot System?

BESPA Charcot System is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Bespa Global, LLC. The 510(k) number is K202326.

When did BESPA Charcot System receive FDA 510(k) clearance?

BESPA Charcot System received FDA 510(k) clearance on 2021-11-09, under 510(k) number K202326.

Who is the listed applicant for BESPA Charcot System?

The FDA 510(k) record lists Bespa Global, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BESPA Charcot System?

The FDA product code for BESPA Charcot System is HWC. This falls under the Cardiovascular category.

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: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

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.