FDA 510(k)

Solitaire 2 and Solitaire Platinum Revascularization Device

Номер K: K181060 · 2018-08-24

Дата решения2018-08-24

Код продуктаPOL

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Solitaire 2 and Solitaire Platinum Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurovascular. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K181060. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Solitaire 2 and Solitaire Platinum Revascularization Device?

Solitaire 2 and Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Medtronic Neurovascular. The 510(k) number is K181060.

When did Solitaire 2 and Solitaire Platinum Revascularization Device receive FDA 510(k) clearance?

Solitaire 2 and Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2018-08-24, under 510(k) number K181060.

Who is the listed applicant for Solitaire 2 and Solitaire Platinum Revascularization Device?

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

What is the FDA product code for Solitaire 2 and Solitaire Platinum Revascularization Device?

The FDA product code for Solitaire 2 and Solitaire Platinum Revascularization Device is POL.

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: POL)

K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited K231539pRESET LITE Thrombectomy DevicePhenox Limited K223305Trevo NXT ProVue RetrieverStryker Neurovascular K222848pRESET Thrombectomy DevicePhenox Limited K210502Trevo NXT ProVue RetrieverStryker Neurovascular K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Официальный источник

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