510(k) K251654
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter by
Becton Dickinson Infusion Therapy Systems, Inc.
— Product Code FOZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2025
- Date Received
- May 30, 2025
- 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