US device clearances
2 510(k) clearances and PMA approvals since 2015
- Seismiq™ Intravascular Lithotripsy System K260246 · 24 Aug 2026
- Bolt Intravascular Lithotripsy (Ivl) System K250225 · 25 Mar 2025
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.