FDA 510(k)

Straub Endovascular System

Номер K: K172315 · 2018-04-12

Дата решения2018-04-12

Код продуктаMCW

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Straub Endovascular System is the device name listed in this FDA 510(k) record. The listed applicant is Straub Medical AG. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K172315. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Straub Endovascular System?

Straub Endovascular System is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Straub Medical AG. The 510(k) number is K172315.

When did Straub Endovascular System receive FDA 510(k) clearance?

Straub Endovascular System received FDA 510(k) clearance on 2018-04-12, under 510(k) number K172315.

Who is the listed applicant for Straub Endovascular System?

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

What is the FDA product code for Straub Endovascular System?

The FDA product code for Straub Endovascular System is MCW.

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: MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

Официальный источник

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