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AcQMap 3D Imaging and Mapping Catheter
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 900009
Identity
- Trade Name
- AcQMap 3D Imaging and Mapping Catheter EUDAMEDAcQMap FDA UDI
- Generic Name
- Cardiac mapping/ultrasound imaging catheter FDA UDI
- Device Name
- AcQMap 3D Imaging and Mapping Catheter EUDAMEDAcQMap 3D Imaging & Mapping Catheter FDA UDI
- Model / Reference
- 900009 EUDAMEDFDA UDI
- Description
- AcQMap 3D Imaging & Mapping Catheter FDA UDI
Identifiers
- Catalog Number
- 900009 FDA UDI
- Primary DI / UDI-DI
- 00857042007401 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857042007ACQMAPCATHNW EUDAMED
- FDA Product Code
- MTD FDA UDIITX FDA UDI
- EMDN Code
- C020105 NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS EUDAMED
- GMDN Term
- Cardiac mapping/ultrasound imaging catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1220 FDA UDI892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
AcQMap 3D Imaging and Mapping Catheter by Acutus Medical, Inc. — Class III — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170819 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K201341 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 0857042007ACQMAPCATHNW | Class III | Active |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
- EUDAMED SRN
- US-MF-000019413
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 06f65e97-1118-4c30-a15a-469abf2da85c 61 fields · synced Jul 14, 2026
- FDA UDI a8132a6d-c21d-4690-a87c-cda045c73ded 36 fields · synced May 30, 2026
- FDA 510(k) K170819 1 fields · synced May 18, 2026