FDA.reportPublic FDA data

CONCERT MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12234141000137702CONCERT MEDICAL, LLC1Y2020-04-2577 ACCORD PARK DR. NORWELL MA US 02061

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
239231828385686K153397S-Wire Guidewire SystemDQX2016-08-18
239231186477571K152991OptoWire DeuxDQX2016-02-11
239231259770183K133625AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &MOF2014-02-24
239231373196190K121776AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIREDQX2012-08-14
239231913147846K090193CONDUCTOR CORONARY GUIDEWIREDQX2009-09-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX42016-08-18
MOF12014-02-24

PMN#

GUDID#