Perclose™ ProStyle™ Suture-Mediated Closure and Repair System
Ref 12773-02
Active
CE MDR
Valid until
12 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 729163 | Date15 Jul 2026 | StatusActive |
Certificates
- MDR 729163 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 15 Jul 2026
- Expires
- 12 Jul 2028
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Suture-Mediated Closure, Perclose ProStyle
- Model / Reference
- 12773-02
- Primary DI / UDI-DI
- 08717648344039
- Basic UDI-DI
- 8717648VCS00044D
- EMDN Code
- C90010303 Haemostasis systems with suture or clip systems
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000003851
- Authorised representative
- Abbott Vascular International BE-AR-000002043
Other devices from Abbott Medical
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No