Cleared Special

ENROUTE? Transcarotid Neuroprotection System

K230402 · Silk Road Medical · Cardiovascular

Apr 2023

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K230402 is an FDA 510(k) clearance for the ENROUTE? Transcarotid Neuroprotection System, a Temporary Carotid Catheter For Embolic Capture (Class II — Special Controls, product code NTE), submitted by Silk Road Medical (Sunnyvale, US). The FDA issued a Cleared decision on April 11, 2023, 55 days after receiving the submission on February 15, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K230402 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2023
Decision Date	April 11, 2023
Days to Decision	55 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	NTE — Temporary Carotid Catheter For Embolic Capture
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	This Device Is A Single Use Percutaneous Catheter System That Is Introduced Into An Artery Through The Skin Using A Guidewire. The Catheter Has An Embolic Capture Filter Or An Occlusion Balloon At The Distal End. The Filter Or Balloon Can Be Placed Either Distally To The Lesion Or Proximally Depending On The Design Of The Device And Intended Use. The Filter Or Balloon Is Used To Capture Embolic Material In A Manner That May Protect Or Prevent A Stroke Or Other Cerebral Vascular Sequelae. The Embolic Capture Device Is Indicated For Use As A Guidewire And Embolic Protection System To Contain And Remove Embolic Material (thrombus/debris) While Performing Angioplasty And Stenting Procedures I