K260916
- 510(k) number
- K260916
- Device name
- FLEXI-PORT Power Injectable Implantable Port
- Applicant
- Portal Access, Inc. FL · US
- Product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascu
- Decision date
- 2026-06-17
- Date received
- 2026-03-19
- 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: K260916.pdf
Official FDA record: K260916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.