Cleared Traditional

PROXIS SYSTEM, MODEL EPS101 (K060651) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 K060651.
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EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
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K030201 · Medtronic Vascular · Mar 2003