Cleared Traditional

TRIACTIV FX EMBOLIC PROTECTION SYSTEM (K061772) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061772 · Kensey Nash Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
18d
Days
Class 2
Risk

K061772 is an FDA 510(k) clearance for the TRIACTIV FX EMBOLIC PROTECTION SYSTEM. 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 July 11, 2006 after a review of 18 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 Kensey Nash Corp. devices

Submission Details

510(k) Number K061772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date July 11, 2006
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K061772.
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · Medtronic, Inc. · Aug 2008
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · Boston Scientific Corp · Aug 2006
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
K051984 · Boston Scientific Corp · Apr 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · Boston Scientific Corp · Nov 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · Boston Scientific Corp · Jun 2005
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · Medtronic Vascular · Mar 2003