Cleared Special

K053197 - TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION

K053197 is an FDA 510(k) clearance for TRUFILL DCS ORBIT DETACHABLE COIL SYSTE..., manufactured by Cordis Neurovascular, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 29-day FDA review.

K053197 · Cordis Neurovascular, Inc. · Neurology device
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Dec 2005
Decision
29d
Days
Class 2
Risk

K053197 is an FDA 510(k) clearance for the TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION. 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 15, 2005 after a review of 29 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. 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.

FDA 510(k) Submission Details - K053197

510(k) Number K053197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date December 15, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K053197.
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K062036 · Micrus Endovascular Corporation · Aug 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · Micro Therapeutics, Inc. · Apr 2006
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K053548 · Protein Polymer Technologies, Inc. · Jan 2006
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
K053160 · Micrus Endovascular Corporation · Dec 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · MicroVention, Inc. · Jun 2005
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560 · Micro Therapeutics, Inc. · Jun 2005
K053197 · TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
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