The following data is part of a premarket notification filed by Soundbite Medical Solutions, Inc. with the FDA for Soundbite Crossing System - Peripheral (14p).
| Device ID | K210839 |
| 510k Number | K210839 |
| Device Name: | SoundBite Crossing System - Peripheral (14P) |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Soundbite Medical Solutions, Inc. 2300 Boulevard Alfred-Nobel Montreal, CA H4s 2a4 |
| Contact | Dominique Abecassis |
| Correspondent | Dominique Abecassis Soundbite Medical Solutions, Inc. 2300 Boulevard Alfred-Nobel Montreal, CA H4s 2a4 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10754026505021 | K210839 | 000 |
| 10754026503027 | K210839 | 000 |
| 10754026501023 | K210839 | 000 |
| 17540265105022 | K210839 | 000 |
| 17540265103028 | K210839 | 000 |
| 17540265101024 | K210839 | 000 |