Cleared Traditional

K081465 - AXIUM DETACHABLE COIL SYSTEM

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

K081465 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K081465

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.

KRD Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K081465.
CONCERTO DETACHABLE COIL SYSTEM
K090046 · Micro Therapeutics, Inc. · Feb 2009
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EMBOZENE MICROSPHERES
K073417 · Celonova Biosciences, Inc. · Dec 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
K073544 · Rj Medical, Inc. · Mar 2008
HYDROCOIL EMBOLIC SYSTEMS (HES)
K071939 · MicroVention, Inc. · Jan 2008
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699 · Aga Medical Corp. · Aug 2007
K081465 · AXIUM DETACHABLE COIL SYSTEM
Download PDF FDA Summary Micro Therapeutics, I…