FDA 510(k)

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

Número K: K231227 · 2023-12-20

Data da decisão2023-12-20

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231227. 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 SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K231227.

When did SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath receive FDA 510(k) clearance?

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231227.

Who is the listed applicant for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

The FDA product code for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is DYB.

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Fonte oficial

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