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FDA 510(k)

ENROUTE Transcarotid Neuroprotection System

K-Number: K153485 · 2016-03-10

ApplicantSilk Road Medical, Inc.
Decision Date2016-03-10
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENROUTE Transcarotid Neuroprotection System is a medical device manufactured by Silk Road Medical, Inc.. It received FDA 510(k) clearance on 2016-03-10 under approval number K153485. 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 2016-03-10. It is manufactured by Silk Road Medical, Inc.. The 510(k) number is K153485.

When was ENROUTE Transcarotid Neuroprotection System approved by the FDA?

ENROUTE Transcarotid Neuroprotection System received FDA 510(k) clearance on 2016-03-10, under approval number K153485.

What company makes ENROUTE Transcarotid Neuroprotection System?

ENROUTE Transcarotid Neuroprotection System is manufactured by Silk Road Medical, Inc..

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

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Official Source

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

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