Medtronic, Ireland: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Medtronic, Ireland” (first 2006, latest 2026), plus 4 PMA decisions, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 182 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 90 |
| 2026 | 3 | 106 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic, Ireland took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 5 | 4 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| MAF | Stent, Coronary | 2 | 0 |
| NIO | Stent, Iliac | 1 | 0 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Review panels
- Cardiovascular (13)
Most recent Medtronic, Ireland 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | LOX | 2026-08-14 | 106 |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | LOX | 2026-07-27 | 60 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | LOX | 2026-01-17 | 205 |
| K252390 | Telescope Guide Extension Catheter | DQY | 2025-10-29 | 90 |
| K250787 | Liberant Thrombectomy System | QEW | 2025-06-11 | 89 |
| K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT | DQY | 2013-04-09 | 182 |
| K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | LOX | 2010-10-22 | 14 |
| K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | DQY | 2006-08-21 | 83 |
| K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM | DQY | 2006-03-16 | 97 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110011 | PMA | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM | 2011-10-26 |
| P030009 | PMA | DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS | 2003-10-01 |
| P970035 | PMA | AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM | 1997-12-23 |
| P790017 | PMA | USCI DILATATION CATHETER | 1980-03-24 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic, Ireland.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtronic, Ireland (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic, Ireland?
FDA lists 9 510(k) clearances under the applicant name “Medtronic, Ireland” (first 2006, latest 2026), plus 4 PMA decisions, across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic, Ireland?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic, Ireland is 90 days. Since 2017: 90 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtronic, Ireland?
The most frequent FDA product codes under this applicant name are LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 5); DQY (Catheter, Percutaneous, 4); MAF (Stent, Coronary, 2).
Next steps
- See all 9 Medtronic, Ireland clearances with predicates and recalls
- Run predicate analysis for product code LOX, Medtronic, Ireland's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.