Cleared Traditional

K143072 - ENROUTE Transcarotid Neuroprotection System

K143072 is an FDA 510(k) clearance for ENROUTE Transcarotid Neuroprotection System, manufactured by Silk Road Medical, Inc.. The device is a Class 2 Cardiovascular device with product code NTE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K143072 · Silk Road Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
105d
Days
Class 2
Risk

K143072 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, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 9, 2015 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Silk Road Medical, Inc. devices

FDA 510(k) Submission Details - K143072

510(k) Number K143072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date February 09, 2015
Days to Decision 105 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

NTE Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01685567 Completed Interventional Industry-sponsored

Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

219
Patients (actual)
21
Sites
Prevention
Purpose
Open label
Masking
Condition studied Carotid Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Christopher Kwolek, MD
Sponsor Silk Road Medical (industry)
Started 2012-11-01 → Primary completion 2016-03-01 → Completed 2016-07-01
Primary outcome
Hierarchical Composite of Stroke, Myocardial Infarction, and Death
Secondary outcome
All Death (Non-hierarchical)
View full study on ClinicalTrials.gov

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 K143072.
ENROUTE Transcarotid Neuroprotection System
K153485 · Silk Road Medical, Inc. · Mar 2016
RX ACCUNET Embolic Protection System
K153086 · Abbott Vascular · Nov 2015
WIRION
K143570 · Gardia Medical · Jun 2015
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · Abbott Vascular · Jul 2014
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · W.L. Gore & Associates, Inc. · Dec 2012
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · Abbott Vascular · May 2012