Cleared Special

K062870 - TRIACTIV FX EMBOLIC PROTECTION SYSTEM

Also marketed or referenced as:
-03

K062870 is an FDA 510(k) clearance for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, manufactured by Kensey Nash Corp.. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Special 510(k) pathway after a 25-day FDA review.

K062870 · Kensey Nash Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
25d
Days
Class 2
Risk

K062870 is an FDA 510(k) clearance for the TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 25 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 Kensey Nash Corp. devices

FDA 510(k) Submission Details - K062870

510(k) Number K062870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date October 20, 2006
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

NFA Device Classification - Class 2, Special Controls

Product Code NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

All 15
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K062870.
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · Medtronic, Inc. · Aug 2008
MODIFICATION TO PROXIS SYSTEM
K073563 · St Jude Medical · Jan 2008
SPIDERFX EMBOLIC PROTECTION DEVICE
K063785 · Ev3, Inc. · Jan 2007
PROXIS SYSTEM, MODEL EPS101
K060651 · St Jude Medical · Sep 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · Boston Scientific Corp · Aug 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K062201 · Ev3, Inc. · Aug 2006