Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter— 510(k) K240954
Substantially EquivalentShockwave Medical, Inc.
FDA 510(k) clearance K240954 for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter, Substantially Equivalent on 2024-05-07. Applicant: Shockwave Medical, Inc..
Clearance details
- Applicant
- Shockwave Medical, Inc.
- Product code
- Code PPN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Adverse events under product code PPN
product code PPN- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.