Device Listing 1263164891

Listing Summary#

Listing key
1263164891
Premarket submission
K262201
Device
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
Applicant
Shockwave Medical, Inc.
Product code
PPN
Decision date
2026-07-27