K210627 is an FDA 510(k) clearance for the Breezeway II. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 3, 2021, 93 days after receiving the submission on March 2, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K210627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2021 |
| Decision Date | June 03, 2021 |
| Days to Decision | 93 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |