# Medtronic, Ireland

- Location (FDA's records): Galway, IE
- FDA decisions: 13 (1980–2026): 9 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: Medtronic, Ireland (11); Medtronic Ireland (2)
- Product codes: LOX (5), DQY (4), MAF (2), QEW (1), NIO (1)
- 510(k) review time since 2016: median 90 days, against 156 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 21 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic, Inc.: 5 (https://510kreport.com/company/medtronic)
- Penumbra, Inc.: 3 (https://510kreport.com/company/penumbra)
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)

## Firms that cite its devices most
- Medtronic, Inc.: 4 (https://510kreport.com/company/medtronic)
- Brosmed Medical Co., Ltd.: 3 (https://510kreport.com/company/brosmed-medical)
- Natec Medical, Ltd.: 2 (https://510kreport.com/company/natec-medical)
- Orbusneich Medical, Inc.: 2 (https://510kreport.com/company/orbusneich-medical)
- Biotronik, Inc.: 2 (https://510kreport.com/company/biotronik)
- Creganna Medical Also Doing Business AS Ceganna Tactx Medica: 1 (https://510kreport.com/company/creganna-medical-also-doing-business-as-ceganna-tactx-medica)
- Meril Life Sciences Private Limited: 1 (https://510kreport.com/company/meril-life-sciences-private)
- Orbusneich Medical Trading, Inc.: 1 (https://510kreport.com/company/orbusneich-medical-trading)

## Its most-cited devices
- P790017: Usci Dilatation Catheter (1980), cited by 13
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon (2010), cited by 4
- K123153: Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select (2013), cited by 2
- K053431: Attain Select II 6248DEL Delivery Catheter System (2006), cited by 2

## Recent decisions
- K261428: NC Euphora Rapid Exchange Balloon Dilatation Catheter (Aug 14, 2026)
- K261759: Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (Jul 27, 2026)
- K251970: Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (Jan 17, 2026)
- K252390: Telescope Guide Extension Catheter (Oct 29, 2025)
- K250787: Liberant Thrombectomy System (Jun 11, 2025)
- K123153: Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select (Apr 9, 2013)
- P110011: Assurant Cobalt Iliac Balloon-Expandable Stent System (Oct 26, 2011)
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon (Oct 22, 2010)

Source page: https://510kreport.com/company/medtronic-ireland