K241587 is an FDA 510(k) clearance for the pilot TLS. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Vygon Corporation (Lansdale Montgomery, US). The FDA issued a Cleared decision on February 26, 2025, 268 days after receiving the submission on June 3, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K241587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2024 |
| Decision Date | February 26, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |