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Creagh Medical Ltd.: FDA-registered device maker in Co. Galway Galway(County), Ireland, 10 510(k) clearances

Name: Creagh Medical Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Creagh Medical Ltd. is registered with the FDA (registration 3005994106) in Co. Galway Galway(County), Ireland. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 15, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005994106
Address: IDA Business Park Ballinasloe, Co. Galway Galway(County), Ireland, H53 K8P4
Owner or operator: Surmodics, Inc (10023361)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 17, 2010
Registered through: 2026
Brand names listed: Advance Serenity® 14 Hydrophilic PTA Balloon Dilatation Catheter, Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter, FirstChoice Ultra High Pressure PTA Balloon Catheters, GORE Molding and Occlusion Balloon (MOB) Catheter, Passeo-35 HP PTA Balloon Dilatation Catheter, Sublime 014 Rx PTA Catheter, Sublime Radial Access 018 PTA Balloon Catheter, Sublime Radial Access Guide Sheath and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 15, 2024	K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical Ltd. Dba Surmodics, Inc.	accessdata.fda.gov
June 16, 2021	K211044	Sublime Radial Access 018 RX Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,	accessdata.fda.gov
May 14, 2020	K200700	Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical, Ltd.	accessdata.fda.gov
April 18, 2019	K190644	Guide Sheath	DYB	Substantially Equivalent	Surmodics,Inc.	accessdata.fda.gov
April 19, 2018	K180007	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical, Ltd.	accessdata.fda.gov
January 12, 2018	K173560	Microcatheter	DQY	Substantially Equivalent	Surmodics,Inc.	accessdata.fda.gov
September 8, 2017	K171251	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical	accessdata.fda.gov
May 19, 2015	K143561	ELM PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	O'Connell Regulatory Consultants, Inc.	accessdata.fda.gov
December 20, 2011	K113468	ELM PTA BALLON DILATATION CATHETER	LIT	Substantially Equivalent	Creagh Medical, Ltd.	accessdata.fda.gov
December 10, 2010	K102645	WILLOW/ELM PTA BALLOON DILATATION CATHETER	LIT	Substantially Equivalent	Creagh Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.