Cleared Traditional

ENLIGHTN RENAL GUIDE CATHETER (K131592) - FDA 510(k) Clearance

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

K131592 · St. Jude Medical, Inc. · Cardiovascular device
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Jan 2014
Decision
242d
Days
Class 2
Risk

K131592 is an FDA 510(k) clearance for the ENLIGHTN RENAL GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 31, 2014 after a review of 242 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, Inc. devices

Submission Details

510(k) Number K131592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date January 31, 2014
Days to Decision 242 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 391
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K131592.
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · Vascular Solutions, Inc. · Feb 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
CONCIERGE GUIDING CATHETER
K132409 · Merit Medical Systems, Inc. · Aug 2013