FDA 510(k)

AcQMap 3D Imaging and Mapping Catheter, Model 900009

N.º K: K210766 · 2022-06-21

Fecha de decisión2022-06-21

Código de productoMTD

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

AcQMap 3D Imaging and Mapping Catheter, Model 900009 is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K210766. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AcQMap 3D Imaging and Mapping Catheter, Model 900009?

AcQMap 3D Imaging and Mapping Catheter, Model 900009 is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210766.

When did AcQMap 3D Imaging and Mapping Catheter, Model 900009 receive FDA 510(k) clearance?

AcQMap 3D Imaging and Mapping Catheter, Model 900009 received FDA 510(k) clearance on 2022-06-21, under 510(k) number K210766.

Who is the listed applicant for AcQMap 3D Imaging and Mapping Catheter, Model 900009?

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

What is the FDA product code for AcQMap 3D Imaging and Mapping Catheter, Model 900009?

The FDA product code for AcQMap 3D Imaging and Mapping Catheter, Model 900009 is MTD.

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Otros registros que enlistan a Acutus Medical, Inc. como solicitante

K233691FlexCath Cross Transseptal Solution K231091AcQMap High Resolution Imaging and Mapping System K230606AcQMap® High Resolution Imaging and Mapping System K222209AcQMap High Resolution Imaging and Mapping System K220784AcQMap High Resolution Imaging and Mapping System K221044AcQGuide® VUE Steerable Sheath

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Dispositivos relacionados (Código: MTD)

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic K241372Catheter de Mapeo de Red HD Advisor™, con Sensor Habilitado™ABBOTT MEDICAL K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Catheter de Mapeo Ablacath™Ablacon, Inc.

Fuente oficial

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