ACUTUS MEDICAL, INC.

Address:2210 Faraday Ave Ste 100,Carlsbad,CA,92008,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer, Diagnostic, Programmable (DQK) (4) Forceps, Wire Holding (HYA) (2) Instruments, Surgical, Cardiovascular (DWS) (2) Electrode, Electrocardiograph (DRX) (1) Introducer, Catheter (DYB) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Catheter, Steerable (DRA) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1) Catheter,Intracardiac Mapping,High-Density Array (MTD) (1) Dilator, Vessel, For Percutaneous Catheterization (DRE) (1)

Premarket Exempt

No Yes

Clear

AcQCross Qx Integrated Transseptal Dilator/Needle - 00850027837611 Catalog Number :

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB, DRE

Prescription Use : Yes

Device Count : 1

DiamondTemp Generator Adapter - 00850027837635 Catalog Number : 800818

Device Description : AcQMap to DiamondTemp Generator Adapter Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : ITX, DQK, IYO

Prescription Use : Yes

Device Count : 1

StabilICE - 00850027837642 Catalog Number : 900221

Device Description : StabilICE

Device Class : 1

Duns Number: 844418199

Premarket Exempt : Yes

Product Code : HYA, DWS

Prescription Use : Yes

Device Count : 1

StabilICE - 00850027837659 Catalog Number : 900218

Device Description : StabilICE

Device Class : 1

Duns Number: 844418199

Premarket Exempt : Yes

Product Code : HYA, DWS

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007005 Catalog Number : 800426

Device Description : North America Power Cord

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

AcQGuide - 00857042007012 Catalog Number : 900002

Device Description : AcQGuide® Steerable Sheath

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007029 Catalog Number : 900003

Device Description : AcQMap® 3D Imaging & Mapping Catheter

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : MTD

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007036 Catalog Number : 800365-002

Device Description : AcQMap® Patient Electrode Kit

Device Class :

Duns Number: 844418199

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007043 Catalog Number : 800258

Device Description : AcQMap® Console

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007050 Catalog Number : 800254

Device Description : AcQMap® Workstation

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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