Cleared Traditional

K063210 - ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488

K063210 is an FDA 510(k) clearance for ATTAIN HYBRID GUIDE WIRES, manufactured by Medtronic Inc. Cardiac Rhythm Management. The device is a Class 2 Cardiovascular device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K063210

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
Combination Product No
PCCP Authorized No
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.

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 696
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K063210.
OSTIAL PRO STENT POSITIONING SYSTEM
K062192 · Ostial Solutions, LLC · May 2007
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007
VASCUPUNCTURE PICC GUIDEWIRE
K070150 · Neometrics, Inc. · Feb 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · Asahi Intecc Co., Ltd. · Jan 2007
LUNDERQUIST WIRE GUIDE
K061670 · William Cook Europe Aps · Jan 2007