Cleared Special

K123813 - VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE

K123813 is an FDA 510(k) clearance for VASCULAR POSITIONING SYSTEM (VPS) G4 CO..., manufactured by Vasonova, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Special 510(k) pathway after a 38-day FDA review.

K123813 · Vasonova, Inc. · Cardiovascular device
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Jan 2013
Decision
38d
Days
Class 2
Risk

K123813 is an FDA 510(k) clearance for the VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Vasonova, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Vasonova, Inc. devices

FDA 510(k) Submission Details - K123813

510(k) Number K123813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2012
Decision Date January 18, 2013
Days to Decision 38 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 63
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