Cleared Traditional

K053265 - MICRUS GUIDE WIRE

K053265 is an FDA 510(k) clearance for MICRUS GUIDE WIRE, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K053265 · Micrus Endovascular Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
157d
Days
Class 2
Risk

K053265 is an FDA 510(k) clearance for the MICRUS GUIDE WIRE, WATUSI 0.014. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (Sunnyvale, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 157 days - an extended review cycle.

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 Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K053265

510(k) Number K053265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2005
Decision Date April 28, 2006
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K053265.
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
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TREASURE
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HI-TORQUE WHISPER VIEW GUIDE WIRE
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TITAN GUIDEWIRE
K060454 · Lake Region Mfg., Inc. · Mar 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · Lake Region Mfg., Inc. · Feb 2006
ASAHI PTCA GUIDE WIRE
K052339 · Asahi Intecc Co., Ltd. · Nov 2005