DeviceClearance

Product code PPN— Cardiovascular

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

Classification name
Percutaneous Catheter, Ultrasound
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
14
First cleared
Most recent

FDA classification definition

“Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.”

— U.S. Food and Drug Administration, device classification record for product code PPN under 21 CFR 870.1250, via openFDA

Market context for product code PPN

FDA has cleared 14 devices under product code PPN between 2016 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PPN

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 →

Recent clearances under product code PPN

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