Cleared Special

K120480 - GORE(R) EMBOLIC FILTER

K120480 is an FDA 510(k) clearance for GORE EMBOLIC FILTER, manufactured by W.L. Gore & Associates. The device is a Class 2 Cardiovascular device with product code NTE cleared through the Special 510(k) pathway after a 29-day FDA review.

K120480 · W.L. Gore & Associates · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
29d
Days
Class 2
Risk

K120480 is an FDA 510(k) clearance for the GORE(R) EMBOLIC FILTER. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by W.L. Gore & Associates (Flagstaff, US). The FDA issued a Cleared decision on March 16, 2012 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.

FDA 510(k) Submission Details - K120480

510(k) Number K120480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2012
Decision Date March 16, 2012
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.

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 35
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K120480.
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
SPIDERFX EMBOLIC PROTECTION DEVICE
K111010 · Ev3, Inc. · Oct 2011
FIBERNET EMBOLIC PROTECTION DEVICE
K111987 · Lumen Biomedical, Inc. · Aug 2011
GORE EMBOLIC FILTER
K103500 · W.L. Gore & Associates, Inc. · May 2011
K120480 · GORE(R) EMBOLIC FILTER
Download PDF FDA Summary W.L. Gore & Associates