Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005994106

FEI Number

3005994106

Entity Name

Creagh Medical Ltd.

City/State/Country

Co. Galway, IE

Establishment Address

IDA Business Park, Ballinasloe, Co. Galway H53 K8P4, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Surmodics, Inc (Owner Number: 10023361)

Owner / Operator Contact Address

9924 W 74th street, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211044

PMA Number

N/A

All Registered Proprietary Names

Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter Sublime 014 Rx PTA Catheter Passeo-35 HP PTA Balloon Dilatation Catheter FirstChoice Ultra High Pressure PTA Balloon Catheters Advance Serenity® 14 Hydrophilic PTA Balloon Dilatation Catheter Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SurVeil Drug-Coated Balloon Sublime Radial Access Guide Sheath FirstChoice Ultra High Pressure PTA Balloon Catheters GORE Molding and Occlusion Balloon (MOB) Catheter Telemark Microcatheter Sublime Radial Access 018 PTA Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-01-23
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2021-03-04
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-01-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-01-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-01-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-07-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-07-03
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2023-08-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-12-04
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2010-12-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-12-17
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2018-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-05-02
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2021-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

Carla Erickson Business: Surmodics Email: cerickson@surmodics.com Phone: (952) 5007258

Related Public Records

Same Entity

Surmodics, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005994106. Last updated year: 2026. Please use registration number 3005994106 when referencing this establishment in official correspondence.