FDA.reportPublic FDA data

SWAV CR SRL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30275453773027545377SWAV CR SRL1N2027-01-01Coyol Free Zone Building B50.B., El Coyol Alajuela CR 20101

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3327901023402901P200039Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) CatheterQMG2021-02-12
3327901257805239K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPN2024-03-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PPN12024-03-22
QMG 12021-02-12