Cleared Special

K181828 - Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile (FDA 510(k) Clearance)

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

K181828 · Scientia Vascular, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
29d
Days
Class 2
Risk

K181828 is an FDA 510(k) clearance for the Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Pr.... Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Scientia Vascular, LLC (West Valley City, US). The FDA issued a Cleared decision on August 7, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scientia Vascular, LLC devices

Submission Details

510(k) Number K181828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date August 07, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - MOF Guide, Wire, Catheter, Neurovasculature

All 39
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