FDA 510(k)

Amsel Occluder Device

Номер K: K172479 · 2017-09-14

Дата решения2017-09-14

Код продуктаFZP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Amsel Occluder Device is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K172479. 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 Occluder Device?

Amsel Occluder Device is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Amsel Medical. The 510(k) number is K172479.

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

Amsel Occluder Device received FDA 510(k) clearance on 2017-09-14, under 510(k) number K172479.

Who is the listed applicant for Amsel Occluder Device?

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

What is the FDA product code for Amsel Occluder Device?

The FDA product code for Amsel Occluder Device 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.

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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

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