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PPN — Percutaneous Catheter, Ultrasound Class II

FDA Device Classification

Classification Details

Product Code
PPN
Device Class
Class II
Regulation Number
870.1250
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K240225shockwave medicalShockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraMarch 22, 2024
K221852shockwave medicalShockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 PeripheraAugust 16, 2022
K221041shockwave medicalShockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemApril 25, 2022
K203365shockwave medicalShockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ PeripherApril 22, 2021
K191840shockwave medicalPeripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and ConnectoAugust 7, 2019
K180958shockwave medicalShockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular July 26, 2018
K180454shockwave medicalShockwave Medical Intravascular Lithotripsy (IVL) SystemJune 27, 2018
K163306shockwave medicalLithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And CoDecember 22, 2016
K161384shockwave medicalLithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and CoSeptember 14, 2016