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Vascular Positioning System (VPS) G4 Console

by Vasonova, Inc.

510(k) K123813

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK123813 Date18 Jan 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1408-2015 FDA Class II initiated 30 Mar 2015

    A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OBJ
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vascular Positioning System (VPS) G4 Console is a medical device that provides real-time guidance for central venous catheter tip placement. It combines electrical cardiac signals (ivECG) and blood flow data (Doppler ultrasound) via a polyimide stylet with a distal Doppler sensor and stainless steel ivECG wire. The console processes these signals to provide visual guidance through a touchscreen tablet display.

This device is supplied as a console system and is intended for use in clinical settings. It is classified as a Class II device under special controls with product code OBJ. The Vascular Positioning System (VPS) G4 Console has received FDA 510(k) clearance (K123813) and is manufactured by Vasonova, Inc. in Menlo Park, US.

Other devices from Vasonova, Inc.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vascular Positioning System (VPS) G4 Console used for?

    The VPS G4 Console is a medical device that provides real-time guidance for central venous catheter tip placement. It combines electrical cardiac signals (ivECG) and blood flow data (Doppler ultrasound) through a polyimide stylet with a distal Doppler sensor and stainless steel ivECG wire, processed to provide visual guidance on a touchscreen tablet display.

  • How is the VPS G4 Console supplied and what is its classification?

    The device is supplied as a console system intended for use in clinical settings. It is classified as a Class II device under special controls with product code OBJ. The Vascular Positioning System (VPS) G4 Console has received FDA 510(k) clearance (K123813) and is manufactured by Vasonova, Inc.

  • Is the VPS G4 Console reusable or single-use?

    The device description does not specify whether the VPS G4 Console is reusable or single-use. The console system is intended for clinical use, but additional information regarding reprocessing or disposal would be required to determine its specific usage classification.

  • What regulatory approvals does the VPS G4 Console have?

    The Vascular Positioning System (VPS) G4 Console has received FDA 510(k) clearance with number K123813. It was classified as substantially equivalent under special controls with product code OBJ and reviewed by the Cardiovascular advisory committee.