The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Shockwave Medical Intravascular Lithotripsy (ivl) System.
| Device ID | K180454 |
| 510k Number | K180454 |
| Device Name: | Shockwave Medical Intravascular Lithotripsy (IVL) System |
| Classification | Percutaneous Catheter, Ultrasound |
| Applicant | Shockwave Medical, Inc. 48501 Warm Springs Blvd Suite 108 Fremont, CA 94539 |
| Contact | Plessy Paul |
| Correspondent | Plessy Paul Shockwave Medical, Inc. 48501 Warm Springs Blvd Suite 108 Fremont, CA 94539 |
| Product Code | PPN |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-06-27 |
| Summary: | summary |