K221041 is an FDA 510(k) clearance for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System. 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 25, 2022, 17 days after receiving the submission on April 8, 2022.
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 | K221041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2022 |
| Decision Date | April 25, 2022 |
| Days to Decision | 17 days |
| Submission Type | Special |
| 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. |