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

Introducer, Catheter (DYB) (6) Computer, Diagnostic, Programmable (DQK) (3) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Transducer, Ultrasonic, Diagnostic (ITX) (3) Catheter, Steerable (DRA) (1)

Premarket Exempt

No Yes

Clear

AcQGuide MAX - 00850027837017 Catalog Number : 900200

Device Description : 12F AcQGuide MAX 2.0 Steerable Sheath

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837055 Catalog Number : 900301

Device Description : AcQCross Qx - AG 71cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837086 Catalog Number : 900300

Device Description : AcQCross Qx - AG 61cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837109 Catalog Number : 900302

Device Description : AcQCross Qx - SL 63cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837123 Catalog Number : 900303

Device Description : AcQCross Qx - VZ 71cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837147 Catalog Number : 900304

Device Description : AcQCross Qx - FC 65cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQCross Qx - 00850027837161 Catalog Number : 900305

Device Description : AcQCross Qx - MAX 70cm

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

AcQMap - 00850027837192 Catalog Number : 800698

Device Description : SmartAblate™ Adapter Cable AcQMap to Catheter

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK, IYO, ITX

Prescription Use : Yes

Device Count : 1

AcQMap - 00850027837222 Catalog Number : 800695

Device Description : AcQMap to SmartAblate Generator Adapter

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK, IYO, ITX

Prescription Use : Yes

Device Count : 1

AcQMap - 00850027837239 Catalog Number : 800696

Device Description : AcQMap to SmartAblate Generator Adapter

Device Class : 2

Duns Number: 844418199

Premarket Exempt : No

Product Code : DQK, IYO, ITX

Prescription Use : Yes

Device Count : 1

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