FDA 510(k)

TRAcelet Compression Device

N.º K: K162027 · 2016-10-21

Fecha de decisión2016-10-21

Código de productoDXC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRAcelet Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K162027. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRAcelet Compression Device?

TRAcelet Compression Device is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Medtronic Vascular. The 510(k) number is K162027.

When did TRAcelet Compression Device receive FDA 510(k) clearance?

TRAcelet Compression Device received FDA 510(k) clearance on 2016-10-21, under 510(k) number K162027.

Who is the listed applicant for TRAcelet Compression Device?

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

What is the FDA product code for TRAcelet Compression Device?

The FDA product code for TRAcelet Compression Device is DXC.

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Fuente oficial

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