Cleared Traditional

K191173 - Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191173 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
85d
Days
Class 2
Risk

K191173 is an FDA 510(k) clearance for the Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on July 25, 2019 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K191173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date July 25, 2019
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.