Cleared Traditional

K203365 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (FDA 510(k) Clearance)

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

K203365 · Shockwave Medical, Inc. · Cardiovascular device
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Apr 2021
Decision
157d
Days
Class 2
Risk

K203365 is an FDA 510(k) clearance for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Perip.... Classified as Percutaneous Catheter, Ultrasound (product code PPN), Class II - Special Controls.

Submitted by Shockwave Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 22, 2021 after a review of 157 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 Shockwave Medical, Inc. devices

Submission Details

510(k) Number K203365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2020
Decision Date April 22, 2021
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
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 K203365.
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