The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Epicardial Access System.
| Device ID | K191546 |
| 510k Number | K191546 |
| Device Name: | Epicardial Access System |
| Classification | Introducer, Catheter |
| Applicant | Baylis Medical Company Inc. 2580 Matheson Blvd. East Mississauga, CA L4w 4j1 |
| Contact | May Tsai |
| Correspondent | May Tsai Baylis Medical Company Inc. 2580 Matheson Blvd. East Mississauga, CA L4w 4j1 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2019-08-02 |