Cleared Traditional

K060747 - FX DETACHABLE COIL SYSTEM

K060747 is the FDA 510(k) clearance for FX DETACHABLE COIL SYSTEM by Micro Therapeutics, Inc.. It is a Class 2 Neurology device (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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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

Submission Details

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.

Device Classification

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 95
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K060747.
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666 · MicroVention, Inc. · Jul 2008
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp · Jul 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · MicroVention, Inc. · Jun 2007
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · Micro Therapeutics, Inc. · Apr 2006
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · MicroVention, Inc. · Jun 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · Boston Scientific Corp · Apr 2005