510(k) K200891
K200891 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System". The FDA issued a decision of Substantially Equivalent on Jun 2, 2021. 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 And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2021
- Date Received
- Apr 3, 2020
- 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
- 510(k)