VIVO System 9002

GUDID 00851424007119

VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the heart with a superimposed activation map, and accurately identify the earliest onset of the arrhythmia. The VIVO™ software comes loaded on a Laptop PC and includes the 3D camera and required accessories.

Catheter Precision, Inc.

Cardiac mapping system application software

• Primary Device ID: 00851424007119
• NIH Device Record Key: af2fc992-28ee-43c7-8665-937de7ebaaf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVO System
• Version Model Number: 9002
• Catalog Number: 9002
• Company DUNS: 131845013
• Company Name: Catheter Precision, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851424007119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200313

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by Catheter Precision, Inc.

• 00851424007089 - VIVO: 2026-02-11 VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the h
• 00085142400710 - VIVO Positioning Patches: 2026-02-11 Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.
• 00851424007119 - VIVO System: 2026-02-11VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the heart with a superimposed activation map, and accurately identify the earliest onset of the arrhythmia. The VIVO™ software comes loaded on a Laptop PC and includes the 3D camera and required accessories.
• 00851424007119 - VIVO System: 2026-02-11 VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the h
• 00851424007157 - LockeT Suture Retention Device: 2026-01-21 LockeT is a safe and effective suture retention device that is used in conjunction with a figure-of-eight suture to achieve hemo