K243224 is an FDA 510(k) clearance for the MitraClip™ G5 Steerable Guide Catheter (SGC0801). This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on December 31, 2024, 85 days after receiving the submission on October 7, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K243224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2024 |
| Decision Date | December 31, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |