Cleared Traditional

K060551 - BRIVANT GUIDEWIRE

K060551 is an FDA 510(k) clearance for BRIVANT GUIDEWIRE, manufactured by Brivant Limited. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K060551 · Brivant Limited · Cardiovascular device
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Jun 2006
Decision
97d
Days
Class 2
Risk

K060551 is an FDA 510(k) clearance for the BRIVANT GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Brivant Limited (Oranmore, Galway, IE). The FDA issued a Cleared decision on June 7, 2006 after a review of 97 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 Brivant Limited devices

FDA 510(k) Submission Details - K060551

510(k) Number K060551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2006
Decision Date June 07, 2006
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 601
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K060551.
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · Asahi Intecc Co., Ltd. · Nov 2006
TREASURE
K061984 · Asahi Intecc Co., Ltd. · Oct 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · Guidant Corp. · Jun 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · Micrus Endovascular Corporation · Apr 2006
TITAN GUIDEWIRE
K060454 · Lake Region Mfg., Inc. · Mar 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · Lake Region Mfg., Inc. · Feb 2006