FDA 510(k)

Wattson Temporary Pacing Guidewire

Номер K: K192454 · 2020-01-15

Дата решения2020-01-15

Код продуктаDQX

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Wattson Temporary Pacing Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K192454. 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 Wattson Temporary Pacing Guidewire?

Wattson Temporary Pacing Guidewire is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Vascular Solutions. The 510(k) number is K192454.

When did Wattson Temporary Pacing Guidewire receive FDA 510(k) clearance?

Wattson Temporary Pacing Guidewire received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192454.

Who is the listed applicant for Wattson Temporary Pacing Guidewire?

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

What is the FDA product code for Wattson Temporary Pacing Guidewire?

The FDA product code for Wattson Temporary Pacing 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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