FDA 510(k)

ENROUTE® Transcarotid Neuroprotection System

Numéro K : K230402 · 2023-04-11

Date de décision2023-04-11

Code produitNTE

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ENROUTE® Transcarotid Neuroprotection System is the device name listed in this FDA 510(k) record. The listed applicant is Silk Road Medical. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K230402. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ENROUTE® Transcarotid Neuroprotection System?

ENROUTE® Transcarotid Neuroprotection System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Silk Road Medical. The 510(k) number is K230402.

When did ENROUTE® Transcarotid Neuroprotection System receive FDA 510(k) clearance?

ENROUTE® Transcarotid Neuroprotection System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K230402.

Who is the listed applicant for ENROUTE® Transcarotid Neuroprotection System?

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

What is the FDA product code for ENROUTE® Transcarotid Neuroprotection System?

The FDA product code for ENROUTE® Transcarotid Neuroprotection System is NTE.

Essais cliniques associés

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Source officielle

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