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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 (117)

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Device	Model / Reference	Registries	Class	Status
FlexCath Cross Transseptal Solution with Flex Sheath	222852	EUDAMED	Class III	Active
AcQMap 3D Imaging and Mapping Catheter	900009	EUDAMEDFDA UDI	Class III	Active
FlexCath Cross Transseptal Solution	900308	EUDAMED	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900300, 900301, 900302, 900303, 900304, 900305, 900306, 900307, 900308, 900309	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution with Mini Sheath	012852	EUDAMEDFDA UDI	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900306	EUDAMED	Class III	Active
AcQGuide Flex Catheter Introducer Sets	222852	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution	900305	EUDAMED	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900304	EUDAMED	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900307	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution	900306	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution	900300	EUDAMEDFDA UDI	Class III	Active
FlexCath Cross Transseptal Solution	900303	EUDAMED	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900305	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution	900304	EUDAMED	Class III	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900302	EUDAMED	Class III	Active
FlexCath Cross Transseptal Solution with Mini Sheath	900310	EUDAMEDFDA UDI	Class III	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

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.