The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Versacross Steerable Sheath, Versacross Transseptal Dilator.
| Device ID | K190688 |
| 510k Number | K190688 |
| Device Name: | VersaCross Steerable Sheath, VersaCross Transseptal Dilator |
| Classification | Introducer, Catheter |
| Applicant | Baylis Medical Company Inc. 2580 Matheson Blvd. E Mississauga, CA L4w 4j1 |
| Contact | May Tsai |
| Correspondent | May Tsai Baylis Medical Company Inc. 2580 Matheson Blvd. E Mississauga, CA L4w 4j1 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447004684 | K190688 | 000 |
| 00685447005780 | K190688 | 000 |
| 00685447005773 | K190688 | 000 |
| 00685447005766 | K190688 | 000 |
| 00685447005759 | K190688 | 000 |
| 00685447005742 | K190688 | 000 |
| 00685447005735 | K190688 | 000 |
| 00685447005810 | K190688 | 000 |
| 00685447005803 | K190688 | 000 |
| 00685447005483 | K190688 | 000 |
| 00685447005490 | K190688 | 000 |
| 00685447004677 | K190688 | 000 |
| 00685447004660 | K190688 | 000 |
| 00685447004653 | K190688 | 000 |
| 00685447004646 | K190688 | 000 |
| 00685447005537 | K190688 | 000 |
| 00685447005520 | K190688 | 000 |
| 00685447005513 | K190688 | 000 |
| 00685447005506 | K190688 | 000 |
| 00685447005797 | K190688 | 000 |