FDA 510(k)

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire

N.º K: K152231 · 2016-02-12

SolicitanteBoston Scientific Corporation

Fecha de decisión2016-02-12

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K152231. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K152231.

When did Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire receive FDA 510(k) clearance?

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire received FDA 510(k) clearance on 2016-02-12, under 510(k) number K152231.

Who is the listed applicant for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire?

The FDA product code for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire is DQX.

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Fuente oficial

Ver en la base de datos de la FDA →

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