FDA 510(k)

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

N.º K: K212268 · 2022-05-27

Fecha de decisión2022-05-27

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT 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 2022-05-27 under 510(k) number K212268. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is FMD Co., Ltd.. The 510(k) number is K212268.

When did FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT receive FDA 510(k) clearance?

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT received FDA 510(k) clearance on 2022-05-27, under 510(k) number K212268.

Who is the listed applicant for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

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 Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT?

The FDA product code for FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT is DQX.

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Otros registros que enlistan a FMD Co., Ltd. como solicitante

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 K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

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.

Fuente oficial

Ver en la base de datos de la FDA →

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