Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
FDA 510(k) clearance K240954 · decided 2024-05-07
Clearance details
- K-number
- K240954
- Device name
- Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-08
- Decision date
- 2024-05-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- PPN
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.