Cleared Traditional

K014041 - TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM

K014041 is an FDA 510(k) clearance for TRUFILL DCS DETACHABLE COIL AND FRUFILL..., manufactured by Cordis Neurovascular. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014041 · Cordis Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
90d
Days
Class 2
Risk

K014041 is an FDA 510(k) clearance for the TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFIL.... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Cordis Neurovascular (Miami Lake, US). The FDA issued a Cleared decision on March 7, 2002 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cordis Neurovascular devices

FDA 510(k) Submission Details - K014041

510(k) Number K014041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2001
Decision Date March 07, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 168
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K014041.
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc. · Jul 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · MicroVention, Inc. · Jul 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · Boston Scientific, Target · Jun 2002
MATRIX DETACHABLE COILS
K012985 · Boston Scientific, Target · Jan 2002
MICROPLEX COIL SYSTEM
K012145 · MicroVention, Inc. · Oct 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000