K251253
- 510(k) number
- K251253
- Device name
- PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port
- Applicant
- Bard Access Systems, Inc. UT · US
- Product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascu
- Decision date
- 2025-06-18
- Date received
- 2025-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251253.pdf
Official FDA record: K251253
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.