Cleared Traditional

K052523 - PROXIS SYSTEM

K052523 is an FDA 510(k) clearance for PROXIS SYSTEM, manufactured by Velocimed, Inc.. The device is a Class 2 Cardiovascular device with product code NFA cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K052523 · Velocimed, Inc. · Cardiovascular device
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Sep 2006
Decision
358d
Days
Class 2
Risk

K052523 is an FDA 510(k) clearance for the PROXIS SYSTEM. Classified as Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (product code NFA), Class II - Special Controls.

Submitted by Velocimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 7, 2006 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Velocimed, Inc. devices

FDA 510(k) Submission Details - K052523

510(k) Number K052523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date September 07, 2006
Days to Decision 358 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
233d slower than avg
Panel avg: 125d · This submission: 358d
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 K052523.
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, 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
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
K061772 · Kensey Nash Corp. · Jul 2006