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FlexCath Cross Transseptal Solution with Mini Sheath
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 900310
Identity
- Trade Name
- FlexCath Cross Transseptal Solution with Mini Sheath EUDAMEDFlexCath Cross Transseptal Solution FDA UDI
- Generic Name
- Cardiac transseptal access electrosurgical dilator/needle FDA UDI
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Model / Reference
- 900310 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027837987 EUDAMED00850027837970 FDA UDI
- Basic UDI-DI
- 0850027837ACQCROSSP3 EUDAMED
- 510(k) Number
- K233691 FDA UDI
- FDA Product Code
- DYB FDA UDIDRE FDA UDI
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
- GMDN Term
- Cardiac transseptal access electrosurgical dilator/needle FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI870.1310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
MR Unsafe FDA UDI
FlexCath Cross Transseptal Solution with Mini Sheath 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233691 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 0850027837ACQCROSSP3 | 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 e3e8ef03-3d7e-421e-ac5e-df2acdaf971e 61 fields · synced Jul 10, 2026
- FDA UDI 1b75a646-f448-4b90-9012-704dff8c39f5 33 fields · synced May 29, 2026
- FDA 510(k) K233691 1 fields · synced May 18, 2026