AtriClip PRO-Mini® LAA Exclusion System
Ref PROM35/A001575-7Model AtriClip ACH35
Active
CE MDR
Valid until
12 Aug 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08401439000000000000016ZQ 10840143914560 | Date23 Jun 2026 | StatusActive |
Certificates
- MDR 754862 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 8 Apr 2026
- Expires
- 12 Aug 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- LAA Exclusion System
- Model / Reference
- AtriClip ACH35, PROM35/A001575-7
- Primary DI / UDI-DI
- 10840143914560
- Basic UDI-DI
- 08401439000000000000016ZQ
- EMDN Code
- P070404 Left atrial appendage occluders
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002974
- Authorised representative
- AtriCure Europe B.V. NL-AR-000000165
Other devices from Atricure, Inc.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No