K252792
- 510(k) number
- K252792
- Device name
- PM2 System with ECGuide Connector
- Applicant
- Piccolo Medical, Inc. CA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2025-11-17
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252792.pdf
Official FDA record: K252792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.