Cleared Traditional

K143316 - Attain Hybrid Guide Wire

K143316 is an FDA 510(k) clearance for Attain Hybrid Guide Wire, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K143316

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.

DQX Device Classification - Class 2, Special Controls

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 615
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K143316.
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Pre-Formed Guidewire
K151244 · Lake Region Medical · Jun 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015
Spring Coil Guidewire
K143135 · Neometrics, Inc. · Feb 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587 · Boston Scientific Corporation · Jan 2015
Hi-Torque JET Guide Wire Family
K142415 · Abbott Vascular, Inc. · Dec 2014