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FDA 510(k)

ENROUTE® Transcarotid Neuroprotection System

K-Number: K230402 · 2023-04-11

ApplicantSilk Road Medical
Decision Date2023-04-11
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Silk Road Medical. The 510(k) number is K230402.

When was ENROUTE® Transcarotid Neuroprotection System approved by the FDA?

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

What company makes ENROUTE® Transcarotid Neuroprotection System?

ENROUTE® Transcarotid Neuroprotection System is manufactured by Silk Road Medical.

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

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

Related Clinical Trials

NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07455747 Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System NOT_YET_RECRUITING

Related Devices (Code: NTE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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