FDA 510(k)

Stent Positioning Assistance System (SPAS)

Номер K: K221917 · 2022-08-19

Дата решения2022-08-19

Код продуктаDQX

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Stent Positioning Assistance System (SPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Seven Sons , Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221917. 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 Stent Positioning Assistance System (SPAS)?

Stent Positioning Assistance System (SPAS) is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Seven Sons , Ltd.. The 510(k) number is K221917.

When did Stent Positioning Assistance System (SPAS) receive FDA 510(k) clearance?

Stent Positioning Assistance System (SPAS) received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221917.

Who is the listed applicant for Stent Positioning Assistance System (SPAS)?

The FDA 510(k) record lists Seven Sons , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stent Positioning Assistance System (SPAS)?

The FDA product code for Stent Positioning Assistance System (SPAS) 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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