Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014779787

FEI Number

3014779787

Entity Name

Creganna Medical S. R. L

City/State/Country

San Rafael Heredia, CR

Establishment Address

400m Este de Holcim, Zona Industrial Flexipark, Bodega G6,, San Rafael Heredia 20108, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CREGANNA MEDICAL IRELAND LIMITED (Owner Number: 9054708)

Owner / Operator Contact Address

Parkmore West, Ballybrit, IE-G H91VN2T, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trevo Trak 21 Microcatheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2022-05-26
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-05-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-05-26
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2018-08-13

Official Correspondent

No official correspondent registered.

US Agent Details

Tafzeelur Rahaman Email: Tafzeelur.rahaman@te.com Phone: (408) 8564459

Related Public Records

Same Entity

CREGANNA MEDICAL IRELAND LIMITED

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004193842	CREGANNA MEDICAL IRELAND LIMITED	BALLYBRIT Galway, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
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

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014779787. Last updated year: 2026. Please use registration number 3014779787 when referencing this establishment in official correspondence.