FDA 510(k)

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

Número K: K241230 · 2024-09-17

Data da decisão2024-09-17

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K241230. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K241230.

When did Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 receive FDA 510(k) clearance?

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 received FDA 510(k) clearance on 2024-09-17, under 510(k) number K241230.

Who is the listed applicant for Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

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

What is the FDA product code for Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

The FDA product code for Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is DYB.

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

K200379Super Sheath K190001Supercath 5 K172496SUPERCATH 5 (26G)K160592SUPERCATH 6

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Fonte oficial

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