Cleared Traditional

K012985 - MATRIX DETACHABLE COILS

K012985 is an FDA 510(k) clearance for MATRIX DETACHABLE COILS, manufactured by Boston Scientific, Target. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K012985 · Boston Scientific, Target · Neurology device
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Jan 2002
Decision
147d
Days
Class 2
Risk

K012985 is an FDA 510(k) clearance for the MATRIX DETACHABLE COILS. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on January 31, 2002 after a review of 147 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Boston Scientific, Target devices

FDA 510(k) Submission Details - K012985

510(k) Number K012985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date January 31, 2002
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
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 155
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K012985.
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc. · Jul 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · MicroVention, Inc. · Jul 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · Boston Scientific, Target · Jun 2002
MICROPLEX COIL SYSTEM
K012145 · MicroVention, Inc. · Oct 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000
GDC ULTRASOFT COIL
K002181 · Boston Scientific, Target · Aug 2000