Cleared Traditional

K060747 - FX DETACHABLE COIL SYSTEM

K060747 is an FDA 510(k) clearance for FX DETACHABLE COIL SYSTEM, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K060747 · Micro Therapeutics, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
400d
Days
Class 2
Risk

K060747 is an FDA 510(k) clearance for the FX DETACHABLE COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on April 24, 2007 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K060747

510(k) Number K060747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date April 24, 2007
Days to Decision 400 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 148d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCG Device Classification - Class 2, Special Controls

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 159
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K060747.
MODIFICATION TO:CONTOUR SE MICROSPHERES
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K071246 · Micrus Endovascular Corporation · Jun 2007
MICRUS MICROCOIL SYSTEM
K070707 · Micrus Endovascular Corporation · Apr 2007
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
K063653 · Micrus Endovascular Corporation · Jan 2007
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254 · Cordis Neurovascular, Inc. · Dec 2006