Cleared Traditional

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

K191173 · Abbott Vascular · Cardiovascular

Jul 2019

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K191173 is an FDA 510(k) clearance for the Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires, a Temporary Carotid Catheter For Embolic Capture (Class II — Special Controls, product code NTE), submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on July 25, 2019, 85 days after receiving the submission on May 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K191173 FDA.gov
FDA Decision	Cleared 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

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