Data / Medical devices / United States / Bolt Medical Inc.
Bolt Medical Inc.: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
Bolt Medical Inc. is registered with the FDA (registration 3041000776) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 24, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3041000776
- Address
- 2131 Faraday Ave, Carlsbad, CA, United States, 92008
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 30, 2025
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percutaneous Catheter, Ultrasound | PPN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2026 | K260246 | SEISMIQ Intravascular Lithotripsy System | PPN | Substantially Equivalent | Bolt Medical, Inc. | accessdata.fda.gov |
| March 25, 2025 | K250225 | Bolt Intravascular Lithotripsy (IVL) System | PPN | Substantially Equivalent | Bolt Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.