Cleared Traditional

K260246 - SEISMIQ™ Intravascular Lithotripsy System

K260246 is an FDA 510(k) clearance for SEISMIQ Intravascular Lithotripsy System, manufactured by Bolt Medical, Inc.. The device is a Class 2 Cardiovascular device with product code PPN cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K260246 · Bolt Medical, Inc. · Cardiovascular device
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Aug 2026
Decision
209d
Days
Class 2
Risk

K260246 is an FDA 510(k) clearance for the SEISMIQ™ Intravascular Lithotripsy 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 August 24, 2026 after a review of 209 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bolt Medical, Inc. devices

FDA 510(k) Submission Details - K260246

510(k) Number K260246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2026
Decision Date August 24, 2026
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PPN Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PPN Percutaneous Catheter, Ultrasound

All 13
Devices cleared under the same product code (PPN) and FDA review panel - the closest regulatory comparables to K260246.
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
K262201 · Shockwave Medical, Inc. · Jul 2026
Bolt Intravascular Lithotripsy (IVL) System
K250225 · Bolt Medical, Inc. · Mar 2025
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