Cleared Traditional

K964367 - CES VASCULAR OCCLUSION SYSTEM

K964367 is an FDA 510(k) clearance for CES 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 90-day FDA review.

K964367 · Cordis Neurovascular, Inc. · Neurology device
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Jan 1997
Decision
90d
Days
Class 2
Risk

K964367 is an FDA 510(k) clearance for the CES VASCULAR OCCLUSION SYSTEM. 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 January 30, 1997 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, Inc. devices

FDA 510(k) Submission Details - K964367

510(k) Number K964367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date January 30, 1997
Days to Decision 90 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
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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K964367.
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
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics · Dec 1996
GUGLIELMI DETACHABLE COIL
K962503 · Target Therapeutics · Sep 1996
BERENSTEIN COIL
K961923 · Target Therapeutics · Aug 1996