K212370 is an FDA 510(k) clearance for the Leaderflex Mini and Leaderflex Nano. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Vygon USA (Lansdale Montgomery, US). The FDA issued a Cleared decision on August 29, 2022, 395 days after receiving the submission on July 30, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K212370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2021 |
| Decision Date | August 29, 2022 |
| Days to Decision | 395 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |