K203365 is an FDA 510(k) clearance for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter. This device is classified as a Percutaneous Catheter, Ultrasound (Class II - Special Controls, product code PPN).
Submitted by Shockwave Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 22, 2021, 157 days after receiving the submission on November 16, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature..
| 510(k) Number | K203365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2020 |
| Decision Date | April 22, 2021 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PPN - Percutaneous Catheter, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature. |