FDA Device Establishments · JSON-LD · Markdown

SWAV CR SRL

FEI 3027545377 · Repack or Relabel Medical Device Manufacture Medical Device · Status: Active

FEI Number3027545377
Owner / OperatorShockwave Medical, Inc. (#10046972)
AddressCoyol Free Zone, Building B50.B., El Coyol, Alajuela, 20101, CR
Mandatory US AgentSHOCKWAVE MEDICAL, INC.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)PPN
Regulation § (21 CFR)870.1250
Proprietary namesShockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

External sources

Source: openFDA. Public-domain (CC0).