Cleared Special

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. (K110909) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K110909 · Abbott Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
29d
Days
Class 2
Risk

K110909 is an FDA 510(k) clearance for the EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORK.... Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on April 29, 2011 after a review of 29 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 Abbott Laboratories devices

Submission Details

510(k) Number K110909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2011
Decision Date April 29, 2011
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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. 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
NCT00402740 Completed Interventional Industry-sponsored

Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)

322
Patients (actual)
38
Sites
Treatment
Purpose
Open label
Masking
Condition studied Carotid Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Seemant Chaturvedi, MD
Sponsor Abbott Medical Devices (industry)
Started 2006-11-01 → Primary completion 2011-06-01 → Completed 2011-10-01
Primary outcome
Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.
Secondary outcome
Acute Device Success
View full study on ClinicalTrials.gov

Regulatory Peers - NTE Temporary Carotid Catheter For Embolic Capture

All 14
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K110909.
WIRION
K180023 · Gardia Medical , Ltd. · Mar 2018
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · W.L. Gore & Associates, Inc. · Dec 2012
GORE EMBOLIC FILTER
K103500 · W.L. Gore & Associates, Inc. · May 2011
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
K101651 · Cordis Corp. · Jul 2010
GORE FLOW REVERSAL SYSTEM
K083300 · W.L. Gore & Associates, Inc. · Feb 2009
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · Abbott Laboratories · Aug 2008