K251212
- 510(k) number
- K251212
- Device name
- Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
- Applicant
- Access Vascular, Inc. MA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2025-07-01
- Date received
- 2025-04-18
- 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: K251212.pdf
Official FDA record: K251212
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.