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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 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#

GUDID#

Telemark™ Microcatheter - The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placementof guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and iscompatible with a 0.014” guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wallthickness and tapers to the distal end. The catheter is available in lengths of 135 cm and 150 cm in length to facilitate access tovarious target sites.

CREAGH MEDICAL LIMITED

2021-07-08

Telemark™ Microcatheter - The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placementof guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and iscompatible with a 0.014” guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wallthickness and tapers to the distal end. The catheter is available in lengths of 135 cm and 150 cm in length to facilitate access tovarious target sites.

CREAGH MEDICAL LIMITED

2021-07-08

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