K232737
- 510(k) number
- K232737
- Device name
- PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- LJT — Port & Catheter, Implanted, Subcutaneous, Intravascu
- Decision date
- 2023-12-08
- Date received
- 2023-09-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232737.pdf
Official FDA record: K232737
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.