Shockwave Medical, Inc. · Class II · Cleared Jul 26, 2018
| K-number | K180958 |
| Device name | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable |
| Applicant | Shockwave Medical, Inc. |
| Product code | PPN |
| Device class | Class II |
| Decision date | Jul 26, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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