AcQCross Qx Integrated Transseptal Dilator/Needle
EUDAMEDFDA 510(k)Class III (EU MDR)
Identity
- Trade Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Model / Reference
- 900302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027837116 EUDAMED
- Basic UDI-DI
- 0850027837ACQCROSSP3 EUDAMED
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The AcQCross Qx Integrated Transseptal Dilator/Needle is a medical device designed to facilitate transseptal access. It functions as an integrated solution that supports both mechanical and radiofrequency puncture techniques.
This device is supplied sterile and is intended for single-use only, as it is not a reusable product. It is identified by reference number 900302 and has received FDA 510(k) clearance and MDR authorization. The device is classified as a Class III medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AcQCross™ Transseptal Access System - Acutus Medical - PDF Catalogs ..., Medtronic 900301 AcQCross™️Qx, Integrated Transseptal Dilator/Needle ..., AcQCross - Integrated Transseptal Dilator/Needle - medical-xprt.com, Medtronic 900301 AcQCross™️Qx, Integrated Transseptal Dilator/Needle ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210685 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K220047 | 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 (2)
- EUDAMED ba5e37d8-4537-4035-89c9-ee0acff35cd6 85 fields · synced Oct 6, 2026
- FDA 510(k) K210685 1 fields · synced May 18, 2026