K241586
- 510(k) number
- K241586
- 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
- 2025-02-27
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K241586.pdf
Official FDA record: K241586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.