VIVO
Catheter Precision, Inc.
Catheter Precision, Incorporated
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010728615 | 3010728615 | Catheter Precision, Incorporated | 1 | N | 2026-01-01 | 1670 Highway 160 West Suite 205 Fort Mill SC US 29708 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 166519 | 1096751099 | K200313 | VIVO | DQK | 2020-09-14 |
| 166519 | 1871009888 | K183195 | VIVO | DQK | 2019-06-14 |
| 166519 | 1665587011 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQK | 2 | 2020-09-14 |
PMN#
VIVO
Catheter Precision, Inc.
GUDID#
VIVO Positioning Patches - Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.
2026-02-03
VIVO - 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.
2026-02-03
VIVO Positioning Patches - Patches are placed on the shoulder and sternum of the patient to acquire an image for VIVO analysis.
2026-02-03
VIVO System - 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.
2026-02-03
LockeT Suture Retention Device - LockeT is a safe and effective suture retention device that is used in conjunction with a figure-of-eight suture to achieve hemostasis after access.
2026-01-13
LockeT Suture Retention Device - LockeT is a safe and effective suture retention device that is used in conjunction with a figure-of-eight suture to achieve hemostasis after access.
2026-01-13
Pharos - A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma
2017-05-04
DABRA Laser System - A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease.
2017-10-13
DABRA 101 Catheter - Percutaneous Catheter
2017-10-13