Creganna Medical Ireland Limited

BALLYBRIT Galway, IE

CREGANNA MEDICAL IRELAND LIMITED appears in FDA device records in BALLYBRIT Galway, IE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 5
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Creganna Medical Ireland Limited carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Creganna Medical Devices510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Creganna Medical Ireland Limited in 2013.

Clearances by year, as a table

510(k) clearance decisions for Creganna Medical Ireland Limited, by decision year
Year	Clearances
2013	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K131079	CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC	DYB	Substantially Equivalent	2013-08-01

Registered establishments

FDA registered establishments for Creganna Medical Ireland Limited, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004193842	3004193842	CREGANNA MEDICAL IRELAND LIMITED	PARKMORE WEST, BALLYBRIT Galway(County) H91VN2T IE	2026	DYB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

DYBIntroducer, Catheter

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2249-2023	Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access	Three lots of product may be labeled with an incorrect expiration day	Class II	2023-06-22	Open, Classified
Z-2532-2017	Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300	Lack of sterility assurance.	Class II	2017-05-22	Terminated
Z-2531-2017	Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400	Lack of sterility assurance.	Class II	2017-05-22	Terminated
Z-2530-2017	Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100	Lack of sterility assurance.	Class II	2017-05-22	Terminated
Z-2529-2017	Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200	Lack of sterility assurance.	Class II	2017-05-22	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain