Cleared Special

K082461 - BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B

K082461 is an FDA 510(k) clearance for BARE PLATINUM FRAMING COIL, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 36-day FDA review.

K082461 · MicroVention, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2008
Decision
36d
Days
Class 2
Risk

K082461 is an FDA 510(k) clearance for the BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V10.... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 36 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. 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 MicroVention, Inc. devices

FDA 510(k) Submission Details - K082461

510(k) Number K082461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2008
Decision Date October 02, 2008
Days to Decision 36 days
Submission Type Special
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
112d faster than avg
Panel avg: 148d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 167
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K082461.
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TRUFILL DCS SYRINGE
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K080666 · MicroVention, Inc. · Jul 2008
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K080379 · Micrus Endovascular Corporation · Jun 2008