Cleared Abbreviated

K042297 - ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES

K042297 is an FDA 510(k) clearance for ULTRA IVALON AND ULTRA DRIVALON PVA EMB..., manufactured by Acta Vascular Systems, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Abbreviated 510(k) pathway after a 281-day FDA review.

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

FDA 510(k) Submission Details - K042297

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.

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 162
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K042297.
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MATRIX STRETCH RESISTANT (SR) COILS
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K042539 · Boston Scientific Corp · Oct 2004