K180958 is an FDA 510(k) clearance for the Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable. This device is classified as a Percutaneous Catheter, Ultrasound (Class II - Special Controls, product code PPN).
Submitted by Shockwave Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on July 26, 2018, 105 days after receiving the submission on April 12, 2018.
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 | K180958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2018 |
| Decision Date | July 26, 2018 |
| Days to Decision | 105 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. |