Sign in Sign up

← Every applicant

Shockwave Medical, Inc. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter510(k)Jul 27, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 27, 2026
Shockwave CS Guide Catheter510(k)May 2, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 2, 2025
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter510(k)Sep 27, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter510(k)May 7, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 7, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter510(k)Mar 22, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter510(k)Aug 16, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 16, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System510(k)Apr 25, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 25, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter510(k)Apr 22, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 22, 2021

Related datasets

FDA RecallsWhat the FDA has made companies pull, and how serious.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.