Cleared Traditional

K250225 - Bolt Intravascular Lithotripsy (IVL) System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K250225 · Bolt Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
57d
Days
Class 2
Risk

K250225 is an FDA 510(k) clearance for the Bolt Intravascular Lithotripsy (IVL) System. Classified as Percutaneous Catheter, Ultrasound (product code PPN), Class II - Special Controls.

Submitted by Bolt Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 25, 2025 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bolt Medical, Inc. devices

Submission Details

510(k) Number K250225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2025
Decision Date March 25, 2025
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PPN Percutaneous Catheter, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05662787 Completed Interventional Industry-sponsored

BOLT Lithotripsy RESTORE ATK Trial

BOLT Lithotripsy RESTORE ATK Trial for PAD (RESTORE ATK)

97
Patients (actual)
11
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease; Peripheral Vascular Diseases
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Bolt Medical (industry)
Started 2023-01-19 → Primary completion 2024-06-20 → Completed 2024-07-30
Primary outcome
Primary Effectiveness Endpoint
Secondary outcome
Freedom from Major Adverse Events (MAEs) within 6 months.
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PPN Percutaneous Catheter, Ultrasound

All 11
Devices cleared under the same product code (PPN) and FDA review panel - the closest regulatory comparables to K250225.
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
K242213 · Shockwave Medical, Inc. · Sep 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
K240954 · Shockwave Medical, Inc. · May 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
K240225 · Shockwave Medical, Inc. · Mar 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
K221852 · Shockwave Medical, Inc. · Aug 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · Shockwave Medical, Inc. · Apr 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
K203365 · Shockwave Medical, Inc. · Apr 2021