The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Shockwave Intravascular Lithotripsy (ivl) System With The Shockwave M5+ Peripheral Ivl Catheter.
| Device ID | K203365 |
| 510k Number | K203365 |
| Device Name: | Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave M5+ Peripheral IVL Catheter |
| Classification | Percutaneous Catheter, Ultrasound |
| Applicant | Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara, CA 95054 |
| Contact | Danica Van |
| Correspondent | Danica Van Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara, CA 95054 |
| Product Code | PPN |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-04-22 |