K221294 is an FDA 510(k) clearance for the preCARDIA Occlusion System. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on June 30, 2023, 422 days after receiving the submission on May 4, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K221294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | May 04, 2022 |
| Decision Date | June 30, 2023 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |