FDA.reportPublic FDA data

Sirtex Wilmington LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055793003005579300Sirtex Wilmington LLC1N2026-01-0116 Upton Drive Unit 2-4 Wilmington MA US 01887

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
721591920172198P990065SIR-SPHERESNAW2002-03-05
721591865088011P220020Lava Liquid Embolic System (Lava LES) and Lava Mixing KitQVG2023-04-04
721591496239358
721591620443216
721591664110596
721591871622136

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAW 12002-03-05