Cleared Traditional

K221852 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (FDA 510(k) Clearance)

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

K221852 · Shockwave Medical, Inc. · Cardiovascular device
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Aug 2022
Decision
50d
Days
Class 2
Risk

K221852 is an FDA 510(k) clearance for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periph.... 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 August 16, 2022 after a review of 50 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 Shockwave Medical, Inc. devices

Submission Details

510(k) Number K221852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2022
Decision Date August 16, 2022
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 K221852.
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 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