# Creagh Medical, Ltd.

- Location (FDA's records): Ballinasloe, IE
- FDA decisions: 6 (2010–2023): 6 510(k) clearances
- Names in FDA's records: Creagh Medical, Ltd. (5); Creagh Medical (1)
- Product codes: LIT (6)
- 510(k) review time since 2016: median 83 days, against 122 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 7 (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
- Invatec Innovative Technologies, S.R.L.: 4 (https://510kreport.com/company/invatec-innovative-technologies)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- O'Connell Regulatory Consultants, Inc.: 1 (https://510kreport.com/company/o-connell-regulatory-consultants)
- Creagh Medical Ltd. Dba Surmodics, Inc.: 1 (https://510kreport.com/company/creagh-medical-dba-surmodics)
- Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,: 1 (https://510kreport.com/company/creagh-medical-a-wholly-owned-subsidiary-of-surmodics)

## Its most-cited devices
- K102645: Willow/Elm Pta Balloon Dilatation Catheter (2010), cited by 4
- K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (2017), cited by 1
- K200700: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (2020), cited by 1
- K180007: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (2018), cited by 1

## Recent decisions
- K230191: Arise™ UHP Dilatation Catheter (Mar 22, 2023)
- K200700: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (May 14, 2020)
- K180007: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (Apr 19, 2018)
- K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (Sep 8, 2017)
- K113468: Elm Pta Ballon Dilatation Catheter (Dec 20, 2011)
- K102645: Willow/Elm Pta Balloon Dilatation Catheter (Dec 10, 2010)

Source page: https://510kreport.com/company/creagh-medical