DeviceClearance

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter— 510(k) K262201

Substantially Equivalent

Shockwave Medical, Inc.

FDA 510(k) clearance K262201 for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter, Substantially Equivalent on 2026-07-27. Applicant: Shockwave Medical, Inc.. Device class: 2.

Summary

Shockwave Medical's clearance names the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter. It's filed under PPN, percutaneous ultrasound catheters, and the record gives no catheter sizes.

Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Shockwave Medical filed from Santa Clara, California. The decision came 28 calendar days after receipt (June 29 to July 27, 2026).

Clearance details

Applicant
Shockwave Medical, Inc.
Product code
Product code PPN
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PPN

product code PPN
Death
16
Total
16

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.