Company
Medtronic Vascular Galway DBA Medtronic Ireland
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2020 | Medtronic Vascular Galway DBA Medtronic Ireland Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. Terminated |
DYB | K181817 |
| Sep 3, 2019 | Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X Open, Classified |
LOX | None listed |
| Sep 3, 2019 | Medtronic Vascular Galway DBA Medtronic Ireland Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X Open, Classified |
LOX | K143480 |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | K143480 |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | K143480 |