FDA 510(k)

Amsel Endo Occluder

Номер K: K180650 · 2018-11-15

Дата решения2018-11-15

Код продуктаFZP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Amsel Endo Occluder is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical Corporation. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K180650. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Amsel Endo Occluder?

Amsel Endo Occluder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Amsel Medical Corporation. The 510(k) number is K180650.

When did Amsel Endo Occluder receive FDA 510(k) clearance?

Amsel Endo Occluder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K180650.

Who is the listed applicant for Amsel Endo Occluder?

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

What is the FDA product code for Amsel Endo Occluder?

The FDA product code for Amsel Endo Occluder is FZP.

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: FZP)

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation K253781InnoClip Clip ApplierTaiwan Surgical Corporation K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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.