K231148 is an FDA 510(k) clearance for the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Vvt Medical , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on June 20, 2023, 60 days after receiving the submission on April 21, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K231148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2023 |
| Decision Date | June 20, 2023 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA - Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |