K241353
- 510(k) number
- K241353
- Device name
- PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- Applicant
- Bard Access Systems, Inc. UT · US
- Product code
- PTI — Non-Coring (Huber) Needle
- Decision date
- 2024-11-27
- Date received
- 2024-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K241353.pdf
Official FDA record: K241353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.