FDA 510(k)

VIVO

N.º K: K200313 · 2020-09-14

Fecha de decisión2020-09-14

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VIVO is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Precision, Inc.. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K200313. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VIVO?

VIVO is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Catheter Precision, Inc.. The 510(k) number is K200313.

When did VIVO receive FDA 510(k) clearance?

VIVO received FDA 510(k) clearance on 2020-09-14, under 510(k) number K200313.

Who is the listed applicant for VIVO?

The FDA 510(k) record lists Catheter Precision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVO?

The FDA product code for VIVO is DQK.

Otros registros que enlistan a Catheter Precision, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K183195VIVO

Dispositivos relacionados (Código: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.