Cleared Traditional

K972881 - CES VASCULAR OCCLUSION SYSTEM

K972881 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 303-day FDA review.

K972881 · Cordis Neurovascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
303d
Days
Class 2
Risk

K972881 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 Lake, US). The FDA issued a Cleared decision on June 4, 1998 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K972881

510(k) Number K972881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date June 04, 1998
Days to Decision 303 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
155d slower than avg
Panel avg: 148d · This submission: 303d
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 K972881.
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · Boston Scientific, Target · Jan 2000
GUGLIELMI DETACHABLE (GDC)
K991139 · Boston Scientific, Target · Dec 1999
VASCULAR OCCLUSION SYSTEM
K983483 · Cordis Neurovascular, Inc. · Mar 1999
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K964021 · Baxter Edwards · Mar 1997
TRUFILL PVA PARTICLES
K965174 · Cordis Neurovascular, Inc. · Mar 1997
CES VASCULAR OCCLUSION SYSTEM
K964367 · Cordis Neurovascular, Inc. · Jan 1997