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Creagh Medical Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059941063005994106Creagh Medical Ltd.1N2026-01-01IDA Business Park Ballinasloe Co. Galway Galway(County) IE H53 K8P4

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1120491442695727K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT2024-11-15
1120491967476307K211044Sublime Radial Access 018 RX Dilatation CatheterLIT2021-06-16
1120491778573353K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterLIT2020-05-14
1120491033317737K190644Guide SheathDYB2019-04-18
1120491388241881K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT2018-04-19
1120491000584744K173560MicrocatheterDQY2018-01-12
1120491221665656K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterLIT2017-09-08
1120491505690532K170635Chameleon PTA Balloon CatheterLIT2017-03-30
1120492018596287K143561ELM PTA Balloon Dilatation CatheterLIT2015-05-19
1120491843391318K113468ELM PTA BALLON DILATATION CATHETERLIT2011-12-20
1120491126546767K102645WILLOW/ELM PTA BALLOON DILATATION CATHETERLIT2010-12-10
1120491027231790K082646OPTIMUS 0.035 PTA BALLOON DILATATION CATHETERDQY2008-11-03
1120491819787453K072156OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETERDQY2007-11-09
1120491393720885
1120491801685484

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT92024-11-15
DQY32018-01-12
DYB12019-04-18

PMN#