Cleared Traditional

K060651 - PROXIS SYSTEM, MODEL EPS101

K060651 is an FDA 510(k) clearance for PROXIS SYSTEM, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K060651 · St Jude Medical · Cardiovascular device
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Sep 2006
Decision
184d
Days
Class 2
Risk

K060651 is an FDA 510(k) clearance for the PROXIS SYSTEM, MODEL EPS101. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by St Jude Medical (Maple Grove, US). The FDA issued a Cleared decision on September 13, 2006 after a review of 184 days - an extended review 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: 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 St Jude Medical devices

FDA 510(k) Submission Details - K060651

510(k) Number K060651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2006
Decision Date September 13, 2006
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 16
Devices cleared under the same product code (NFA) and FDA review panel - the closest regulatory comparables to K060651.
MODIFICATION TO PROXIS SYSTEM
K073563 · St Jude Medical · Jan 2008
SPIDERFX EMBOLIC PROTECTION DEVICE
K063785 · Ev3, Inc. · Jan 2007
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02
K062870 · Kensey Nash Corp. · Oct 2006
PROXIS SYSTEM
K052523 · Velocimed, Inc. · 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