K221397 is an FDA 510(k) clearance for the MitraClip G4 Steerable Guide Catheter. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on September 28, 2022, 138 days after receiving the submission on May 13, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K221397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2022 |
| Decision Date | September 28, 2022 |
| Days to Decision | 138 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |