Bolt Medical, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
SEISMIQ Intravascular Lithotripsy System510(k)Aug 24, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 24, 2026
Bolt Intravascular Lithotripsy (IVL) System510(k)Mar 25, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 25, 2025