FDA 510(k)

Medline Integrated Arterial Catheter

Номер K: K210548 · 2022-05-17

Дата решения2022-05-17

Код продуктаDQX

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Medline Integrated Arterial Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Centurion Medical Products. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K210548. 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 Medline Integrated Arterial Catheter?

Medline Integrated Arterial Catheter is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Centurion Medical Products. The 510(k) number is K210548.

When did Medline Integrated Arterial Catheter receive FDA 510(k) clearance?

Medline Integrated Arterial Catheter received FDA 510(k) clearance on 2022-05-17, under 510(k) number K210548.

Who is the listed applicant for Medline Integrated Arterial Catheter?

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

What is the FDA product code for Medline Integrated Arterial Catheter?

The FDA product code for Medline Integrated Arterial Catheter 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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