FDA 510(k)

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

Número K: K240460 · 2024-06-13

Data da decisão2024-06-13

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is the device name listed in this FDA 510(k) record. The listed applicant is FMD Co., Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K240460. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is FMD Co., Ltd.. The 510(k) number is K240460.

When did FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) receive FDA 510(k) clearance?

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240460.

Who is the listed applicant for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

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

What is the FDA product code for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)?

The FDA product code for FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) is DQX.

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Outros registros que listam FMD Co., Ltd. como candidato(a)

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 40 K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

Dispositivos Relacionados (Código: 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.

Fonte oficial

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