Cleared Traditional

K063210 - ATTAIN HYBRID GUIDE WIRES

K063210 is the FDA 510(k) clearance for ATTAIN HYBRID GUIDE WIRES by Medtronic Inc. Cardiac Rhythm Management. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K063210 · Medtronic Inc. Cardiac Rhythm Management · Cardiovascular device
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Mar 2007
Decision
143d
Days
Class 2
Risk

K063210 is an FDA 510(k) clearance for the ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronic Inc. Cardiac Rhythm Management (Shoreview, US). The FDA issued a Cleared decision on March 15, 2007 after a review of 143 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. Cardiac Rhythm Management devices

Submission Details

510(k) Number K063210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2006
Decision Date March 15, 2007
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K063210.
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · Asahi Intecc Co., Ltd. · Jul 2007
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · Asahi Intecc Co., Ltd. · Jan 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372 · Terumo Medical Corp. · Jan 2007
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · Asahi Intecc Co., Ltd. · Nov 2006