FDA 510(k)

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035

Número K: K261281 · 2026-09-03

Data da decisão2026-09-03

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 is the device name listed in this FDA 510(k) record. The listed applicant is Filmecc Co., Ltd.. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K261281. 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 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035?

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Filmecc Co., Ltd.. The 510(k) number is K261281.

When did CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 receive FDA 510(k) clearance?

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 received FDA 510(k) clearance on 2026-09-03, under 510(k) number K261281.

Who is the listed applicant for CROSSLEAD Standard 035 and CROSSLEAD Stiff 035?

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

What is the FDA product code for CROSSLEAD Standard 035 and CROSSLEAD Stiff 035?

The FDA product code for CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 is DQX.

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