Cleared Traditional

K180454 - Shockwave Medical Intravascular Lithotripsy (IVL) System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180454 · Shockwave Medical, Inc. · Cardiovascular device
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Jun 2018
Decision
127d
Days
Class 2
Risk

K180454 is an FDA 510(k) clearance for the Shockwave Medical Intravascular Lithotripsy (IVL) System. Classified as Percutaneous Catheter, Ultrasound (product code PPN), Class II - Special Controls.

Submitted by Shockwave Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on June 27, 2018 after a review of 127 days - within the typical 510(k) review window.

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 Shockwave Medical, Inc. devices

Submission Details

510(k) Number K180454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2018
Decision Date June 27, 2018
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 11
Devices cleared under the same product code (PPN) and FDA review panel - the closest regulatory comparables to K180454.
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
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · Shockwave Medical, Inc. · Apr 2022