Cleared Traditional

K052659 - SPIDERX EMBOLIC PROTECTION DEVICE

K052659 is the FDA 510(k) clearance for SPIDERX EMBOLIC PROTECTION DEVICE by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code NTE) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K052659 · Ev3, Inc. · Cardiovascular device
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Feb 2006
Decision
143d
Days
Class 2
Risk

K052659 is an FDA 510(k) clearance for the SPIDERX 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 February 17, 2006 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ev3, Inc. devices

Submission Details

510(k) Number K052659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date February 17, 2006
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 K052659.
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
SPIDERFX EMBOLIC PROTECTION DEVICE
K063204 · Ev3, Inc. · Nov 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