510(k) K250682
K250682 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector". The FDA issued a decision of Substantially Equivalent on June 3, 2025. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2025
- Date Received
- March 6, 2025
- Clearance Type
- Traditional
- 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