The following data is part of a premarket notification filed by Soundbite Medical Solution Inc. with the FDA for Soundbite Console, Soundbite Active Wire 18.
| Device ID | K192211 |
| 510k Number | K192211 |
| Device Name: | SoundBite Console, SoundBite Active Wire 18 |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | SoundBite Medical Solution Inc. 2300 Blvd Alfred Nobel Montreal, CA H4s 2a4 |
| Contact | Marc Andre Cote |
| Correspondent | Marc Andre Cote SoundBite Medical Solution Inc. 2300 Blvd Alfred Nobel Montreal, CA H4s 2a4 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-14 |
| Decision Date | 2020-01-17 |