Cleared Abbreviated

ACTA VESSEL OCCLUSION SYSTEM (VOS) (K091952) - FDA 510(k) Clearance

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

K091952 · Nfocus Neuromedical, Inc. · Cardiovascular device
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Sep 2010
Decision
436d
Days
Class 2
Risk

K091952 is an FDA 510(k) clearance for the ACTA VESSEL OCCLUSION SYSTEM (VOS). Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Nfocus Neuromedical, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 436 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Nfocus Neuromedical, Inc. devices

Submission Details

510(k) Number K091952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date September 10, 2010
Days to Decision 436 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 125d · This submission: 436d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 127
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