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FDA 510(k)

Bolt Intravascular Lithotripsy (IVL) System

K-Number: K250225 · 2025-03-25

ApplicantBolt Medical, Inc.
Decision Date2025-03-25
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bolt Intravascular Lithotripsy (IVL) 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 2025-03-25 under 510(k) number K250225. 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 Bolt Intravascular Lithotripsy (IVL) System?

Bolt Intravascular Lithotripsy (IVL) System is a medical device that received FDA 510(k) clearance on 2025-03-25. The listed applicant is Bolt Medical, Inc.. The 510(k) number is K250225.

When did Bolt Intravascular Lithotripsy (IVL) System receive FDA 510(k) clearance?

Bolt Intravascular Lithotripsy (IVL) System received FDA 510(k) clearance on 2025-03-25, under 510(k) number K250225.

Who is the listed applicant for Bolt Intravascular Lithotripsy (IVL) 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 Bolt Intravascular Lithotripsy (IVL) System?

The FDA product code for Bolt Intravascular Lithotripsy (IVL) 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_RECRUITINGNCT05007925Disrupt PAD BTK II Study With the Shockwave Peripheral IVL SystemCOMPLETEDNCT05058456Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemCOMPLETEDNCT05072730ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2COMPLETEDNCT05145478CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral LesionsRECRUITINGNCT05291247Shockwave IVL + DESCOMPLETED

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.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.K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave 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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