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Acutus Medical, Inc.

United States·US-MF-000019413

Last updated May 27, 2026

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)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
AcQRef	900005	FDA UDI	Class II	Unknown
AcQMap	800113	FDA UDI	Class II	Unknown
AcQMap	800244-001	FDA UDI	Class II	Unknown
AcQGuide	112852	FDA UDI	Class II	Active
AcQMap	800424	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900308-003	FDA UDI	Class II	Active
Mini Sheath with FlexCath Cross	012852-005	FDA UDI	Class II	Active
FlexCath Cross Transseptal Solution	900304-003	FDA UDI	Class II	Active
AcQMap	900100	FDA UDI	Class II	Unknown
AcQMap	800229	FDA UDI	Class II	Unknown
AcQMap	800696	FDA UDI	Class II	Unknown
AcQMap	800710	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900305-003	FDA UDI	Class II	Active
AcQMap	800421	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900309-003	FDA UDI	Class II	Active
AcQCross Qx	900305	FDA UDI	Class II	Active
AcQMap	800604	FDA UDI	Class II	Unknown
AcQMap	900000	FDA UDI	Class II	Unknown
AcQMap	800697	FDA UDI	Class II	Unknown
AcQMap	800500	FDA UDI	Class II	Unknown
AcQMap	800745	FDA UDI	Class II	Unknown
AcQGuide	900002	FDA UDI	Class II	Unknown
AcQGuide VUE	900201	FDA UDI	Class II	Active
FlexCath Cross Transseptal Solution	900307-003	FDA UDI	Class II	Active
AcQMap	800522	FDA UDI	Class II	Unknown
AcQMap	800601	FDA UDI	Class II	Unknown
StabilICE	900218	FDA UDI	Class I	Unknown
FlexCath Cross Transseptal Solution	900306-003	FDA UDI	Class II	Active
AcQMap	900003	FDA UDI	Class II	Unknown
AcQMap	800365-002	FDA UDI	Class II	Unknown
AcQMap	800523	FDA UDI	Class II	Unknown
AcQMap	800739	FDA UDI	Class II	Unknown
AcQMap	800605	FDA UDI	Class II	Unknown
AcQMap	800109	FDA UDI	Class II	Unknown
AcQMap	800112	FDA UDI	Class II	Unknown
AcQGuide MAX	900200	FDA UDI	Class II	Unknown
AcQMap	800254	FDA UDI	Class II	Unknown
AcQMap	800422	FDA UDI	Class II	Unknown
AcQMap	800255	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900303-003	FDA UDI	Class II	Active
AcQMap	800524	FDA UDI	Class II	Unknown
AcQMap	800748	FDA UDI	Class II	Unknown
FlexCath Cross Transseptal Solution	900300-003	FDA UDI	Class II	Active
AcQCross Qx	900302	FDA UDI	Class II	Active
AcQCross Qx Integrated Transseptal Dilator/Needle	900306	FDA UDI	Class II	Active
AcQMap	800742	FDA UDI	Class II	Unknown
AcQGuide Flex	222852	FDA UDI	Class II	Active
AcQMap	800431	FDA UDI	Class II	Unknown
AcQCross Qx	900301	FDA UDI	Class II	Active
DiamondTemp Generator Adapter	800818	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

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.

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.