Cleared Special

K181828 - Volo 14 Guidewire

K181828 is an FDA 510(k) clearance for Volo 14 Guidewire, manufactured by Scientia Vascular, LLC. The device is a Class 2 Neurology device with product code MOF cleared through the Special 510(k) pathway after a 29-day FDA review.

K181828 · Scientia Vascular, LLC · Neurology device
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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

FDA 510(k) Submission Details - K181828

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MOF Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K181828.
Aristotle 18 Guidewire, 200cm, Soft Profile
K183608 · Scientia Vascular, LLC · Mar 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070 · Asahi Intecc Co., Ltd. · Jan 2019
HYBRID Guidewire
K182337 · Balt USA, LLC · Oct 2018
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K171613 · Asahi Intecc Co., Ltd. · Jul 2017
Traxcess 7 Mini XSoft Guidewire
K163154 · MicroVention, Inc. · Dec 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · Asahi Intecc Co., Ltd. · Oct 2016