BD FlowSmart Set, MiniMed Pro-Set
FDA 510(k) K160651 · Becton, Dickinson and Company
510(k) numberK160651
Submission
- Device name
- BD FlowSmart Set, MiniMed Pro-Set
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- March 8, 2016
- Decision date
- April 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was BD FlowSmart Set, MiniMed Pro-Set cleared by the FDA?
BD FlowSmart Set, MiniMed Pro-Set (K160651) received a 510(k) decision of Substantially Equivalent on April 7, 2016, 30 days after the submission was received.
What is the product code of K160651?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.