FDA 510(k)

CrossTorq 14 Guidewire

Número K: K193194 · 2019-12-13

Data da decisão2019-12-13

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CrossTorq 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Cardio Access, LLC. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193194. 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 CrossTorq 14 Guidewire?

CrossTorq 14 Guidewire is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Scientia Cardio Access, LLC. The 510(k) number is K193194.

When did CrossTorq 14 Guidewire receive FDA 510(k) clearance?

CrossTorq 14 Guidewire received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193194.

Who is the listed applicant for CrossTorq 14 Guidewire?

The FDA 510(k) record lists Scientia Cardio Access, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossTorq 14 Guidewire?

The FDA product code for CrossTorq 14 Guidewire is DQX.

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