The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Expansure Transseptal Dilation System.
| Device ID | K182064 |
| 510k Number | K182064 |
| Device Name: | ExpanSure Transseptal Dilation System |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga, CA L4w 4p7 |
| Contact | May Tsai |
| Correspondent | May Tsai Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga, CA L4w 4p7 |
| Product Code | DRE |
| Subsequent Product Code | DQY |
| Subsequent Product Code | DYB |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2019-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447003038 | K182064 | 000 |
| 00685447003021 | K182064 | 000 |
| 00685447004707 | K182064 | 000 |
| 00685447004691 | K182064 | 000 |