# VIVO System

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vivo-system-9002-001>
- Manufacturer: [Catheter Precision, Inc](https://devicerts.com/manufacturers/catheter-precision-inc) (United States)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: DQK
- EMDN: V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
- GMDN: Cardiac mapping system application software (44783)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00851424007089 · listed 2026-02-03 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 08514240079002-001VR · UDI-DI 00851424007089 · registered 2024-02-28 · status: Active
- **510(k)** · FDA 510(k) · United States · K200313 · issued 2020-09-14 · status: Active
- **510(k)** · FDA 510(k) · United States · K183195 · issued 2019-06-14 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: VIVO System [EUDAMED]; VIVO [FDA GUDID (AccessGUDID)]
- Generic name: Cardiac mapping system application software [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 9002-001 [EUDAMED]; 9002 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00851424007089 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 08514240079002-001VR [EUDAMED]
- Direct marketing DI: 00851424007089 [EUDAMED]
- 510(k) Number: K200313 [FDA GUDID (AccessGUDID)]
- FDA product code: DQK [FDA GUDID (AccessGUDID)]
- EMDN code: V92 [EUDAMED]
- GMDN term: Cardiac mapping system application software (44783) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.1425 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: VIVO System, Catheter Precision, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/vivo-system-9002-001 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/vivo-system-9002-001.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vivo-system-9002-001
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.