Cleared Special

K102818 - MICRUS ONE 2 ONE GUIDEWIRE

K102818 is an FDA 510(k) clearance for MICRUS ONE 2 ONE GUIDEWIRE, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 66-day FDA review.

K102818 · Micrus Endovascular Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
66d
Days
Class 2
Risk

K102818 is an FDA 510(k) clearance for the MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (San Jose, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K102818

510(k) Number K102818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date December 03, 2010
Days to Decision 66 days
Submission Type Special
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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 K102818.
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ARCHER SUPER STIFF GUIDEWIRES
K101339 · Medtronic, Inc. · Aug 2010