Creagh Medical Ltd.
Co. Galway Galway, IE
Creagh Medical Ltd. appears in FDA device records in Co. Galway Galway, IE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Creagh Medical Ltd. between 2010 and 2023. The busiest year on record is 2010, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230191 | Arise™ UHP Dilatation Catheter | LIT | Substantially Equivalent | |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | LIT | Substantially Equivalent | |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005994106 | 3005994106 | Creagh Medical Ltd. | IDA Business Park, Co. Galway Galway(County) H53 K8P4 IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain