Cleared Special

ADROIT Guiding Catheter (K143412) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K143412 · Cordis Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
47d
Days
Class 2
Risk

K143412 is an FDA 510(k) clearance for the ADROIT Guiding Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cordis Corporation (Fremont, US). The FDA issued a Cleared decision on January 14, 2015 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corporation devices

Submission Details

510(k) Number K143412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date January 14, 2015
Days to Decision 47 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

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 323
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K143412.
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
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · Codman & Shurtleff, Inc. · Apr 2014
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014