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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 a medical device manufactured by Bolt Medical, Inc.. It received FDA 510(k) clearance on 2025-03-25 under approval 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. It is manufactured by Bolt Medical, Inc.. The 510(k) number is K250225.

When was Bolt Intravascular Lithotripsy (IVL) System approved by the FDA?

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

What company makes Bolt Intravascular Lithotripsy (IVL) System?

Bolt Intravascular Lithotripsy (IVL) System is manufactured by Bolt Medical, Inc..

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

NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06662500 FORWARD CAD IDE Study RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07510438 AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING

Related Devices (Code: PPN)

K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector CableShockwave Medical, Inc. K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CableShockwave Medical, Inc. K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector CableShockwave Medical, Inc. K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)Shockwave Medical, Inc. K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ 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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