Cleared Traditional

CPS Direct MediGuide Enabled outer catheter (K142239) - FDA 510(k) Clearance

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

K142239 · St Jude Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
127d
Days
Class 2
Risk

K142239 is an FDA 510(k) clearance for the CPS Direct MediGuide Enabled outer catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by St Jude Medical (Sylmar, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 127 days - within the typical 510(k) review window.

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 K142239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date December 18, 2014
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 292
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K142239.
YOGA Microcatheter
K162563 · Codman & Shurtleff, Inc. · Jan 2017
Stingray LP Catheter
K152401 · Boston Scientific Corporation · Dec 2015
Coda LP Balloon Catheter
K150970 · Cook Incorporated · May 2015
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · Cook, Inc. · Jan 2014
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
K132673 · Medtronic, Inc. · Oct 2013