K241587
- 510(k) number
- K241587
- Device name
- pilot TLS
- Applicant
- Vygon Corporation PA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2025-02-26
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241587.pdf
Official FDA record: K241587
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.