Cleared Traditional

K063313 - FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM...

K063313 is the FDA 510(k) clearance for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code NTE) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K063313 · Boston Scientific Corp · Cardiovascular device
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Dec 2006
Decision
33d
Days
Class 2
Risk

K063313 is an FDA 510(k) clearance for the FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM). Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Mountain View, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 33 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.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K063313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2006
Decision Date December 05, 2006
Days to Decision 33 days
Submission Type Traditional
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
92d faster than avg
Panel avg: 125d · This submission: 33d
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.

Regulatory Peers - NTE Temporary Carotid Catheter For Embolic Capture

All 19
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K063313.
GORE FLOW REVERSAL SYSTEM
K083300 · W.L. Gore & Associates, Inc. · Feb 2009
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · Abbott Laboratories · Aug 2008
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
K072990 · Medtronic, Inc. · Oct 2007
SPIDERFX EMBOLIC PROTECTION DEVICE
K063204 · Ev3, Inc. · Nov 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K052659 · Ev3, Inc. · Feb 2006
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
K042908 · Guidant Corp. · Nov 2004