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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07458243A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese PopulationNOT_YET_RECRUITING

Other records listing Silk Road Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterK153485ENROUTE Transcarotid Neuroprotection System

Related Devices (Code: NTE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis CorporationK210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott VascularK180023WIRIONGardia Medical , Ltd.

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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