Cleared Special

K090046 - CONCERTO DETACHABLE COIL SYSTEM

K090046 is the FDA 510(k) clearance for CONCERTO DETACHABLE COIL SYSTEM by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 51-day FDA review.

K090046 · Micro Therapeutics, Inc. · Cardiovascular device
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Feb 2009
Decision
51d
Days
Class 2
Risk

K090046 is an FDA 510(k) clearance for the CONCERTO DETACHABLE COIL SYSTEM. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K090046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2009
Decision Date February 27, 2009
Days to Decision 51 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 95
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K090046.
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
K093002 · MicroVention, Inc. · Oct 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882 · MicroVention, Inc. · Jul 2009
COOK MREYE EMBOLIZATION COILS
K090624 · Cook, Inc. · Apr 2009
AXIUM DETACHABLE COIL SYSTEM
K081465 · Micro Therapeutics, Inc. · Aug 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · MicroVention, Inc. · Jan 2008
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · Cook, Inc. · Dec 2006