K243484
- 510(k) number
- K243484
- Device name
- PM2+ System and SmartPICC Stylet
- Applicant
- Piccolo Medical, Inc. CA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2025-05-29
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243484.pdf
Official FDA record: K243484
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.