K230865
- 510(k) number
- K230865
- Device name
- PIVO Pro Needle-free Blood Collection Device
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc. UT · US
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2023-09-28
- Date received
- 2023-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K230865.pdf
Official FDA record: K230865
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.