FDA.reportPublic FDA data

TRIREME MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080893603008089360TRIREME MEDICAL, LLC1N2020-04-257060 Koll Center Parkway Suite 300 Pleasanton CA US 94566

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1100841162891866K153682Chocolate XD PTCA Balloon CatheterLOX2016-06-23
1100841822345781K133633CHOCOLATE PTCA BOLLOON CATHETERLOX2014-06-02
1100841120008720K121681GLIDER PTCA BALLOON CATHETERLOX2012-06-26
1100841176916559K103534GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIREDQY2011-01-05
1100841894038252K101062GLIDER PTA BALLOON CATHETERLIT2010-05-12
1100841701077953
1100842066043110

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX32016-06-23
DQY12011-01-05
LIT12010-05-12

PMA#

PMN#

GUDID#

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