K222679 is an FDA 510(k) clearance for the Vericor Support Catheter. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Vascupatent Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 7, 2022, 62 days after receiving the submission on September 6, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K222679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2022 |
| Decision Date | November 07, 2022 |
| Days to Decision | 62 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 |