Medtronic, Ireland
Country not established FDA
- Devices
- 11
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Medtronic, Ireland makes
The company manufactures coronary and peripheral vascular interventional devices, including rapid-exchange and over-the-wire balloon dilatation catheters (e.g., Sprinter Legend, Gruntzig Dilaca), guide catheters (e.g., Attain Command, Telescope), stent systems (e.g., Integrity, S7 with Discrete Technology, Assurant Cobalt), and thrombectomy systems (e.g., Liberant). These products are designed for percutaneous coronary and iliac artery interventions, such as angioplasty, stent placement, and clot removal.
The portfolio includes devices regulated as Class II and Class III under the FDA, with submissions recorded via 510(k) clearances and PMA authorisations. The company’s products are listed in the US market and are manufactured by a subsidiary based in Ireland, operating under US regulatory oversight.
Catalogue
Search and filter all 11 devicesFDA establishments
- Medtronic Ireland GALWAY Galway(County) · IE FEI 3002806434
Frequently asked questions
How many devices does Medtronic, Ireland have in the registry?
The registry currently lists 11 devices for Medtronic, Ireland. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic, Ireland's devices?
Among its 11 most recently registered devices, Medtronic, Ireland has devices listed in FDA 510(k) (7 devices) and FDA PMA (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medtronic, Ireland's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Medtronic, Ireland's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic, Ireland in the registry?
The most recently registered devices listed for Medtronic, Ireland include SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON, ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY, ATTAIN SELECT, ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM and Sprinter Legend Rapid Exchange Balloon Dilatation Catheter.
Which FDA establishments are linked to Medtronic, Ireland?
1 FDA establishment is linked to Medtronic, Ireland in the registry; they are listed on the company page.