FDA 510(k)

Medtronic Confida Brecker Guidewire

Номер K: K181001 · 2018-05-03

Дата решения2018-05-03

Код продуктаDQX

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Medtronic Confida Brecker Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Core Valve, LLC. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K181001. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Medtronic Confida Brecker Guidewire?

Medtronic Confida Brecker Guidewire is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Medtronic Core Valve, LLC. The 510(k) number is K181001.

When did Medtronic Confida Brecker Guidewire receive FDA 510(k) clearance?

Medtronic Confida Brecker Guidewire received FDA 510(k) clearance on 2018-05-03, under 510(k) number K181001.

Who is the listed applicant for Medtronic Confida Brecker Guidewire?

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

What is the FDA product code for Medtronic Confida Brecker Guidewire?

The FDA product code for Medtronic Confida Brecker Guidewire is DQX.

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: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

Официальный источник

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