Cleared Traditional

K063254 - THE TRUFILL DCS DETACHABLE COIL SYSTEM

Also marketed or referenced as:
THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

K063254 is the FDA 510(k) clearance for THE TRUFILL DCS DETACHABLE COIL SYSTEM by Cordis Neurovascular, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K063254 · Cordis Neurovascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
41d
Days
Class 2
Risk

K063254 is an FDA 510(k) clearance for the THE TRUFILL DCS DETACHABLE COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lake, US). The FDA issued a Cleared decision on December 7, 2006 after a review of 41 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. 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 Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K063254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2006
Decision Date December 07, 2006
Days to Decision 41 days
Submission Type Traditional
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
107d faster than avg
Panel avg: 148d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K063254.
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp · Jul 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · MicroVention, Inc. · Jun 2007
FX DETACHABLE COIL SYSTEM
K060747 · Micro Therapeutics, Inc. · Apr 2007
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · Micro Therapeutics, Inc. · Apr 2006
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K053197 · Cordis Neurovascular, Inc. · Dec 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · MicroVention, Inc. · Jun 2005