Cleared Special

K143412 - ADROIT Guiding Catheter

K143412 is an FDA 510(k) clearance for ADROIT Guiding Catheter, manufactured by Cordis Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 47-day FDA review.

K143412 · Cordis Corporation · Cardiovascular device
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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

FDA 510(k) Submission Details - K143412

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.

DQY Device Classification - Class 2, Special Controls

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 622
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K143412.
Headway 27 Microcatheter
K142449 · MicroVention, Inc. · Mar 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · Asahi Intecc Co., Ltd. · Mar 2015
Benchmark Intracranial Access System
K142321 · Penumbra, Inc. · Jan 2015
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235 · St Jude Medical · Dec 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · St Jude Medical · Dec 2014
TURNPIKE CATHETER
K142065 · Vascular Solutions, Inc. · Nov 2014