FDA 510(k)

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

Número K: K161912 · 2016-10-14

Data da decisão2016-10-14

Código do produtoMOF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161912. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161912.

When did ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161912.

Who is the listed applicant for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

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

What is the FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

The FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is MOF.

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

K254178SAYA 86 Radial Access Guide Catheter K252011CHIKAI Nexus petit K251560FUBUKI XF-R Neurovascular Long Sheath K251240Branchor X Balloon Guide Catheter K243383CHIKAI Nexus 014 K243733SION blue PLUS

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Dispositivos Relacionados (Código: MOF)

K254181Aristotle 65 MacrowireScientia Vascular K26075135 Helix GuidewirePiraeus Medical, Inc.K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.

Fonte oficial

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