K221470 is an FDA 510(k) clearance for the Langston dual lumen catheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Vascular Solutions, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 17, 2022, 28 days after receiving the submission on May 20, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K221470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | June 17, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |