Cleared Special

K153086 - RX ACCUNET Embolic Protection System

K153086 is an FDA 510(k) clearance for RX ACCUNET Embolic Protection System, manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code NTE cleared through the Special 510(k) pathway after a 25-day FDA review.

K153086 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
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Nov 2015
Decision
25d
Days
Class 2
Risk

K153086 is an FDA 510(k) clearance for the RX ACCUNET Embolic Protection System. 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 November 20, 2015 after a review of 25 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 Vascular devices

FDA 510(k) Submission Details - K153086

510(k) Number K153086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date November 20, 2015
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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. 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 33
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K153086.
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · Abbott Vascular · Jul 2019
WIRION
K180023 · Gardia Medical , Ltd. · Mar 2018
ENROUTE Transcarotid Neuroprotection System
K153485 · Silk Road Medical, Inc. · Mar 2016
WIRION
K143570 · Gardia Medical · Jun 2015
ENROUTE Transcarotid Neuroprotection System
K143072 · Silk Road Medical, Inc. · Feb 2015
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · Abbott Vascular · Jul 2014