Cleared Abbreviated

ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES (K042297) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K042297 · Acta Vascular Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
281d
Days
Class 2
Risk

K042297 is an FDA 510(k) clearance for the ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Acta Vascular Systems, Inc. (Los Gatos, US). The FDA issued a Cleared decision on June 1, 2005 after a review of 281 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Acta Vascular Systems, Inc. devices

Submission Details

510(k) Number K042297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date June 01, 2005
Days to Decision 281 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 148d · This submission: 281d
Pathway characteristics
Standards-based clearance path.

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 184
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K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024