Bolt Intravascular Lithotripsy (IVL) System
FDA 510(k) clearance K250225 · decided 2025-03-25
Clearance details
- K-number
- K250225
- Device name
- Bolt Intravascular Lithotripsy (IVL) System
- Applicant
- Bolt Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-27
- Decision date
- 2025-03-25
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- PPN
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.