The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Epicardial Access System.
| Device ID | K213582 |
| 510k Number | K213582 |
| Device Name: | Epicardial Access System |
| Classification | Introducer, Catheter |
| Applicant | Baylis Medical Company Inc. 5825 Explorer Dr. Mississauga, CA L4W 5P6 |
| Contact | May Tsai |
| Correspondent | May Tsai Baylis Medical Company Inc. 5825 Explorer Dr. Mississauga, CA L4W 5P6 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-12 |
| Decision Date | 2022-06-30 |