K212228 is an FDA 510(k) clearance for the WATCHMAN FXD Curve Access System. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on August 13, 2021, 28 days after receiving the submission on July 16, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K212228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | August 13, 2021 |
| 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 |