K202154 is an FDA 510(k) clearance for the B-Capta. This device is classified as a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DRY).
Submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on April 1, 2021, 241 days after receiving the submission on August 3, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.
| 510(k) Number | K202154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2020 |
| Decision Date | April 01, 2021 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRY - Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4330 |