K240486
- 510(k) number
- K240486
- Device name
- PM2 System and ECGuide Connector
- Applicant
- Piccolo Medical, Inc. CA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2024-09-08
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K240486.pdf
Official FDA record: K240486
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.