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Acutus Medical, Inc.

United States·US-MF-000019413

Last updated May 27, 2026

What Acutus Medical, Inc. makes

The company designs and manufactures electrosurgical tools and kits for cardiac transseptal access, including dilators, needles, and single-use guide-catheters. These products are used in procedures requiring interatrial passage, such as ablation and structural heart interventions. Examples include the AcQGuide and FlexCath Cross Transseptal Solution, as well as mini sheaths paired with transseptal catheters.

The portfolio includes devices classified as Class II and Class III under global regulations. Products are listed in the EU’s eudamed database, the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Acutus Medical, Inc. manufacture?

Acutus Medical, Inc. specializes in electrosurgical tools and kits designed for cardiac transseptal access procedures. These include transseptal access electrosurgical dilators/needles, transseptal access sets, and single-use vascular guide-catheters. The devices are primarily used in interventions requiring interatrial passage, such as cardiac ablation and structural heart repairs.

Where is Acutus Medical, Inc. based?

The company is headquartered in the United States. Its location influences regulatory pathways, particularly for devices marketed in the U.S. and globally, though individual device authorizations depend on compliance with regional requirements like FDA or EU regulations.

Which regulatory registries list Acutus Medical’s devices?

Acutus Medical’s devices are included in multiple regulatory databases: the EU’s eudamed system, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These registries help track and verify device listings for compliance and transparency.

How are Acutus Medical’s devices classified under global regulations?

Acutus Medical’s devices fall into Class II and Class III classifications under global regulatory frameworks. Class III typically applies to higher-risk devices like those used in critical cardiac procedures (e.g., transseptal access), requiring stricter premarket approval processes, while Class II devices may undergo 510(k) clearance or equivalent pathways.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 2210, Faraday Ave., Carlsbad, United States
Website: www.acutusmedical.com/int/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-442-232-6103
PRRC Contact: Sarah Clay
EUDAMED SRN: US-MF-000019413
FDA FEI Number: —
DUNS Number: 844418199

Catalogue (113)

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Device	Model / Reference	Registries	Class	Status
AcQMap®	800365-003	FDA UDI	Class II	Unknown
AcQMap	800407	FDA UDI	Class II	Unknown
AcQMap	800426	FDA UDI	Class II	Unknown
AcQGuide MAX	900200-003	FDA UDI	Class II	Unknown
AcQCross Qx Integrated Transseptal Dilator/Needle	900309	FDA UDI	Class II	Active
AcQMap	800695	FDA UDI	Class II	Unknown
AcQGuide	122852	FDA UDI	Class II	Active
AcQCross Qx	900304	FDA UDI	Class II	Active
FlexCath Cross Transseptal Solution	900302-003	FDA UDI	Class II	Active
AcQMap	800520	FDA UDI	Class II	Unknown
AcQCross Qx Integrated Transseptal Dilator/Needle	900308	FDA UDI	Class II	Active
AcQMap	800430	FDA UDI	Class II	Unknown
AcQGuide Mini	212852	FDA UDI	Class II	Active
StabilICE	900221	FDA UDI	Class I	Unknown
DiamondTemp Generator Adapter	800727	FDA UDI	Class II	Unknown
AcQMap	800530	FDA UDI	Class II	Unknown
AcQCross Qx	900303	FDA UDI	Class II	Active
StabilICE	900218	FDA UDI	Class I	Unknown
AcQMap	800531	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900301-003	FDA UDI	Class II	Active
AcQMap	800698	FDA UDI	Class II	Unknown
AcQMap	800505	FDA UDI	Class II	Unknown
AcQMap	800405	FDA UDI	Class II	Unknown
AcQCross Qx Integrated Transseptal Dilator/Needle	900307	FDA UDI	Class II	Active
AcQMap	800508	FDA UDI	Class II	Unknown
AcQMap	800258	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution with Mini Sheath	900311	EUDAMEDFDA UDI	Class III	Active
FlexCath Cross Transseptal Solution	900301	EUDAMED	Class III	Active
AcQMap High Resolution Imaging and Mapping System	K193013	FDA 510(k)	Class II	Active
AcQMap 3D Imaging and Mapping Catheter, Model 900009	K210766	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K201015	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K191392	FDA 510(k)	Class II	Active
AcQMap® High Resolution Imaging and Mapping System	K230606	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K220784	FDA 510(k)	Class II	Active
AcQRef Introducer Sheath	K192106	FDA 510(k)	Class II	Active
AcQGuide MAX Steerable Sheath	K211100	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K212345	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K170948	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K181577	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K190131	FDA 510(k)	Class II	Active
AcQGuide Steerable Sheath	K162925	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K222209	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K210680	FDA 510(k)	Class II	Active
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX	K193509	FDA 510(k)	Class II	Active
AcQRef Introducer Sheath	K171557	FDA 510(k)	Class II	Active
AcQMap High Resolution Imaging and Mapping System	K231091	FDA 510(k)	Class II	Active
AcQGuide® VUE Steerable Sheath	K221044	FDA 510(k)	Class II	Active
FlexCath Cross Transseptal Solution	900302	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution with Flex Sheath	222852	EUDAMED	Class III	Active
AcQMap 3D Imaging and Mapping Catheter	900009	EUDAMEDFDA UDI	Class III	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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Authorities

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Acutus Medical, Inc. has four recall records, all initiated on February 25, 2020, with each listed as terminated. The recalls were due to the potential presence of foreign material particulates on finished devices, which could affect procedural outcomes.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 25, 2020	Z-1771-2020	—	terminated	It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Feb 25, 2020	Z-1770-2020	—	terminated	It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Feb 25, 2020	Z-1769-2020	—	terminated	It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Feb 25, 2020	Z-1768-2020	—	terminated	It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.