Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr Catheters
by Arrow International LLC (Subsidiary of Teleflex Incorporated)
Ref AD-09903
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08019020000000000000121K5 10801902194814 | Date18 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Multi-Lumen Access Catheter (MAC) & Percutaneous Sheath Introducer (PSI) Product
- Model / Reference
- AD-09903
- Primary DI / UDI-DI
- 10801902194814
- Basic UDI-DI
- 08019020000000000000121K5
- EMDN Code
- C0502 Cardiovascular introducer sheaths, valved
- Device Class
- Class IIb
- Medical Purpose
- The Arrow Multi-Lumen Central Venous Access Device permits venous access for procedures requiring large volume fluid infusion or catheter introduction to the central circulation
Manufacturer details
- EUDAMED SRN
- US-PR-000023158
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