Cleared Special

K080967 - TRUFILL DCS ORBIT DETACHABLE COIL AND T...

K080967 is the FDA 510(k) clearance for TRUFILL DCS ORBIT DETACHABLE COIL AND T... by Cordis Neurovascular, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 28-day FDA review.

K080967 · Cordis Neurovascular, Inc. · Neurology device
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May 2008
Decision
28d
Days
Class 2
Risk

K080967 is an FDA 510(k) clearance for the TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRI.... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 28 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.

View all Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K080967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2008
Decision Date May 02, 2008
Days to Decision 28 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: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K080967.
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K082461 · MicroVention, Inc. · Oct 2008
TRUFILL DCS SYRINGE
K082324 · Cordis Neurovascular, Inc. · Sep 2008
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666 · MicroVention, Inc. · Jul 2008
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
K071962 · Cordis Neurovascular, Inc. · Sep 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp · Jul 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · MicroVention, Inc. · Jun 2007