Cleared Special

K090168 - AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

K090168 is an FDA 510(k) clearance for AZUR DETACTABLE 18, 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 48-day FDA review.

K090168 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
48d
Days
Class 2
Risk

K090168 is an FDA 510(k) clearance for the AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415. 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 March 12, 2009 after a review of 48 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.

FDA 510(k) Submission Details - K090168

510(k) Number K090168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2009
Decision Date March 12, 2009
Days to Decision 48 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
101d faster than avg
Panel avg: 149d · This submission: 48d
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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K090168.
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K091641 · MicroVention, Inc. · Jun 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891 · MicroVention, Inc. · Jun 2009
HYDROFRAME (HES)
K090357 · MicroVention, Inc. · Apr 2009
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
K090001 · MicroVention, Inc. · Mar 2009
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
K083646 · Micrus Endovascular Corporation · Jan 2009
MICRUS MICROCOIL DELIVERY SYSTEM
K082739 · Micrus Endovascular Corporation · Oct 2008
K090168 · AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
Download PDF FDA Summary MicroVention, Inc.