K231311 is an FDA 510(k) clearance for the CPS Direct™ Universal slittable outer guide catheter (DS2C029). This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on June 2, 2023, 28 days after receiving the submission on May 5, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K231311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2023 |
| Decision Date | June 02, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |