Cleared Traditional

K031852 - SAPPHIRE DETACHABLE FIBER COILS

K031852 is the FDA 510(k) clearance for SAPPHIRE DETACHABLE FIBER COILS by Micro Therapeutics, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K031852 · Micro Therapeutics, Inc. · Neurology device
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Aug 2003
Decision
65d
Days
Class 2
Risk

K031852 is an FDA 510(k) clearance for the SAPPHIRE DETACHABLE FIBER COILS. 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 August 20, 2003 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K031852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date August 20, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
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 103
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K031852.
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · Micro Therapeutics, Inc. · Sep 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · Boston Scientific Corp · Sep 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542 · Boston Scientific Corp · Sep 2003
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
K022735 · MicroVention, Inc. · Sep 2002
CONTOUR SE MICROSPHERES
K022427 · Boston Scientific Corp · Aug 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc. · Jul 2002