Cleared Special

K052165 - RX ACCUNET EMBOLIC PROTECTION SYSTEM

K052165 is an FDA 510(k) clearance for RX ACCUNET EMBOLIC PROTECTION SYSTEM, manufactured by Guidant Corporation. The device is a Class 2 Cardiovascular device with product code NTE cleared through the Special 510(k) pathway after a 7-day FDA review.

K052165 · Guidant Corporation · Cardiovascular device
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Aug 2005
Decision
7d
Days
Class 2
Risk

K052165 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 Guidant Corporation (Santa Clara, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 7 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 Guidant Corporation devices

FDA 510(k) Submission Details - K052165

510(k) Number K052165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2005
Decision Date August 16, 2005
Days to Decision 7 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
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 23
Devices cleared under the same product code (NTE) and FDA review panel - the closest regulatory comparables to K052165.
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
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