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) (8) Electrode, Electrocardiograph (DRX) (1) Introducer, Catheter (DYB) (1)

Premarket Exempt

No Yes

Clear

AcQMap - 00857042007067 Catalog Number : 800244-001

Device Description : AcQMap® Ablation Interface Unit

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007074 Catalog Number : 800430

Device Description : Ampere® Adapter CableAcQMap® → Ablation Catheter

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007081 Catalog Number : 800229

Device Description : AcQMap® Patient Interface Unit

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007098 Catalog Number : 800113

Device Description : AcQMap® Patient Interface Unit Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007104 Catalog Number : 800112

Device Description : AcQMap® Ablation Interface Unit Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007111 Catalog Number : 800109

Device Description : AcQMap® Auxiliary Catheter Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007128 Catalog Number : 800407

Device Description : AcQMap® Surface ECG Cable

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQMap - 00857042007135 Catalog Number : 800431

Device Description : Ampere® Adapter Cable AcQMap®→ Ampere

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

AcQRef - 00857042007142 Catalog Number : 900005

Device Description : AcQRef Introducer Sheath

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

AcQMap® - 00857042007210 Catalog Number : 800365-003

Device Description : Patient Electrode Kit 900100

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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