The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Expansure Large Access Transseptal Dilator.
| Device ID | K201288 |
| 510k Number | K201288 |
| Device Name: | ExpanSure Large Access Transseptal Dilator |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-14 |
| Decision Date | 2020-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447005278 | K201288 | 000 |
| 00685447005261 | K201288 | 000 |
| 00685447005254 | K201288 | 000 |
| 00685447005247 | K201288 | 000 |