Cleared Special

K230402 - ENROUTE® Transcarotid Neuroprotection System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230402 · Silk Road Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2023
Decision
55d
Days
Class 2
Risk

K230402 is an FDA 510(k) clearance for the ENROUTE® Transcarotid Neuroprotection System. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Silk Road Medical (Sunnyvale, US). The FDA issued a Cleared decision on April 11, 2023 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Silk Road Medical devices

Submission Details

510(k) Number K230402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NTE Temporary Carotid Catheter For Embolic Capture
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - NTE Temporary Carotid Catheter For Embolic Capture

All 35
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K230402.
EmPro EPS (EP4514C-190, EP6514C-190)
K222694 · MicroVention, Inc. · Apr 2023
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
K220654 · Cordis Corporation · Apr 2022
WIRION Embolic Protection System
K210282 · Cardiovascular Systems, Inc. · Mar 2021
WIRION
K200198 · Cardiovascular Systems, Inc. · Mar 2020