510(k) K181718
K181718 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD FlowSmart Set/MiniMed Pro-Set". The FDA issued a decision of Substantially Equivalent on Oct 18, 2018. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 2018
- Date Received
- Jun 29, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)