K252478
- 510(k) number
- K252478
- Device name
- Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
- Applicant
- Bard Access Systems, Inc. UT · US
- Product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascu
- Decision date
- 2025-09-05
- Date received
- 2025-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252478.pdf
Official FDA record: K252478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.