The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Breezeway Ii.
| Device ID | K210627 |
| 510k Number | K210627 |
| Device Name: | Breezeway II |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DeSoto Boulevard Palm Harbor, FL 34683 |
| Contact | Doug Myers |
| Correspondent | Doug Myers Oscor Inc. 3816 DeSoto Boulevard Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-02 |
| Decision Date | 2021-06-03 |