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FDA 510(k)

SEISMIQ™ Intravascular Lithotripsy System

K-Number: K260246 · 2026-08-24

ApplicantBolt Medical, Inc.
Decision Date2026-08-24
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEISMIQ™ Intravascular Lithotripsy System is the device name listed in this FDA 510(k) record. The listed applicant is Bolt Medical, Inc.. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K260246. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEISMIQ™ Intravascular Lithotripsy System?

SEISMIQ™ Intravascular Lithotripsy System is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is Bolt Medical, Inc.. The 510(k) number is K260246.

When did SEISMIQ™ Intravascular Lithotripsy System receive FDA 510(k) clearance?

SEISMIQ™ Intravascular Lithotripsy System received FDA 510(k) clearance on 2026-08-24, under 510(k) number K260246.

Who is the listed applicant for SEISMIQ™ Intravascular Lithotripsy System?

The FDA 510(k) record lists Bolt Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEISMIQ™ Intravascular Lithotripsy System?

The FDA product code for SEISMIQ™ Intravascular Lithotripsy System is PPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06181240Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)ACTIVE_NOT_RECRUITING

Other records listing Bolt Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250225Bolt Intravascular Lithotripsy (IVL) System

Related Devices (Code: PPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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