Cleared Traditional

K081465 - AXIUM DETACHABLE COIL SYSTEM

K081465 is the FDA 510(k) clearance for AXIUM DETACHABLE COIL SYSTEM by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K081465 · Micro Therapeutics, Inc. · Cardiovascular device
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Aug 2008
Decision
84d
Days
Class 2
Risk

K081465 is an FDA 510(k) clearance for the AXIUM 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 August 19, 2008 after a review of 84 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. 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 K081465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date August 19, 2008
Days to Decision 84 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081465.
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882 · MicroVention, Inc. · Jul 2009
COOK MREYE EMBOLIZATION COILS
K090624 · Cook, Inc. · Apr 2009
CONCERTO DETACHABLE COIL SYSTEM
K090046 · Micro Therapeutics, Inc. · Feb 2009
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · MicroVention, Inc. · Jan 2008
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · Cook, Inc. · Dec 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · Boston Scientific Corporation · Jan 2006