Cleared Traditional

K983483 - VASCULAR OCCLUSION SYSTEM

K983483 is an FDA 510(k) clearance for VASCULAR OCCLUSION SYSTEM, manufactured by Cordis Neurovascular, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K983483 · Cordis Neurovascular, Inc. · Neurology device
Download Printable Device Report (PDF)
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Mar 1999
Decision
170d
Days
Class 2
Risk

K983483 is an FDA 510(k) clearance for the VASCULAR OCCLUSION 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 March 24, 1999 after a review of 170 days - an extended review 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: 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, Inc. devices

FDA 510(k) Submission Details - K983483

510(k) Number K983483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date March 24, 1999
Days to Decision 170 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
22d slower than avg
Panel avg: 148d · This submission: 170d
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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K983483.
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
K993417 · Boston Scientific, Target · Jan 2000
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · Boston Scientific, Target · Jan 2000
GUGLIELMI DETACHABLE (GDC)
K991139 · Boston Scientific, Target · Dec 1999
CES VASCULAR OCCLUSION SYSTEM
K972881 · Cordis Neurovascular, Inc. · Jun 1998
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K964021 · Baxter Edwards · Mar 1997
TRUFILL PVA PARTICLES
K965174 · Cordis Neurovascular, Inc. · Mar 1997