510(k) K163513
Arrow Endurance Extended Dwell Peripheral Catheter System by
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
— Product Code FOZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2017
- Date Received
- December 15, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type