Cleared Special

K063204 - SPIDERFX EMBOLIC PROTECTION DEVICE

K063204 is the FDA 510(k) clearance for SPIDERFX EMBOLIC PROTECTION DEVICE by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code NTE) cleared through the Special 510(k) pathway after a 22-day FDA review.

K063204 · Ev3, Inc. · Cardiovascular device
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Nov 2006
Decision
22d
Days
Class 2
Risk

K063204 is an FDA 510(k) clearance for the SPIDERFX EMBOLIC PROTECTION DEVICE. Classified as Temporary Carotid Catheter For Embolic Capture (product code NTE), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 14, 2006 after a review of 22 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 Ev3, Inc. devices

Submission Details

510(k) Number K063204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2006
Decision Date November 14, 2006
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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. 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 K063204.
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · Abbott Laboratories · Aug 2008
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
K072990 · Medtronic, Inc. · Oct 2007
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · Boston Scientific Corp · Dec 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K052659 · Ev3, Inc. · Feb 2006
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
K042908 · Guidant Corp. · Nov 2004
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
K042218 · Guidant Corp. · Aug 2004