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Vasonova, Inc.

United StatesFDA applicant, unverified

Devices
8
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Vasonova, Inc. makes

Vasonova, Inc. manufactures vascular positioning systems, including consoles and stylets for guiding catheters, as well as central venous catheters and associated consoles designed for improved vascular access. Their product line includes the Vascular Positioning System (VPS) consoles and catheters, alongside the FlowPiCC catheter and console for peripheral insertion. These devices are intended for use in medical procedures requiring precise catheter placement.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database. Vasonova, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • Vascular Positioning System (Vps) G4 Console Ref K123813

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vascular Positioning System (Vps System) Console Ref K103260

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flowpicc Catheter Ref K083920

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flowpicc Console Ref K081626

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vps Catheter Ref K091924

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flowpicc Catheter Ref K082481

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vascular Positioning System Tm (Vps Tm System) Stylet Ref K103255

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flowpicc Stylet Ref K081625

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Vasonova, Inc., initiated on 2015-03-30. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 30 Mar 2015 Z-1408-2015 Class II Terminated A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1. Distribution: US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC. Submission number: K123813

Frequently asked questions

How many devices does Vasonova, Inc. have in the registry?

The registry currently lists 8 devices for Vasonova, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vasonova, Inc.'s devices?

Among its 8 most recently registered devices, Vasonova, Inc. has devices listed in FDA 510(k) (8 devices).

What risk classes do Vasonova, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for Vasonova, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Vasonova, Inc.?

FDA recall records list 1 recall initiated by Vasonova, Inc., the most recent initiated on 30 Mar 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Vasonova, Inc. in the registry?

The most recently registered devices listed for Vasonova, Inc. include VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE, VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE, FLOWPICC CATHETER and FLOWPICC CONSOLE.

Generated automatically from registry data and not verified by a human reviewer.