K251422
- 510(k) number
- K251422
- Device name
- BD Saf-T-Intima Subcutaneous Catheter System
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc. UT · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-10-08
- Date received
- 2025-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251422.pdf
Official FDA record: K251422
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.