Cleared Traditional

K143316 - Attain Hybrid Guide Wire

K143316 is the FDA 510(k) clearance for Attain Hybrid Guide Wire by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K143316 · Medtronic, Inc. · Cardiovascular device
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Mar 2015
Decision
112d
Days
Class 2
Risk

K143316 is an FDA 510(k) clearance for the Attain Hybrid Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 11, 2015 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Medtronic, Inc. devices

Submission Details

510(k) Number K143316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date March 11, 2015
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 380
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K143316.
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587 · Boston Scientific Corporation · Jan 2015
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · Merit Medical Systems, Inc. · Dec 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · Merit Medical Systems, Inc. · Dec 2014