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Bolt Intravascular Lithotripsy (IVL) System

by Bolt Medical, Inc. 510(k)

Active United States

510(k) K250225

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250225 Date25 Mar 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 12 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PPN
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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