Chrysalis Intelligence · Sponsors · Medtronic, Ireland

Medtronic, Ireland

Galway, IE · 5 510(k) clearances · 12 PMAs

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Total clearances
5
2025-06-11 → 2026-08-14
Last 12 months
4
Product codes
3
Most recent
2026-08-14
Name variants in FDA filings: Medtronic Ireland / Medtronic, Ireland
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LOX — — — 3 2026-08-14
DQY — — — 1 2025-10-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 1 2025-06-11
Class III

PMA approvals (12)

Total PMA records
12
Originals + supplements
Distinct product codes
1
First decision
2020-06-02
Most recent
2022-07-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2022-07-15 P030009-S101 Integrity Coronary Stent Systems 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2022-04-19 P030009-S107 Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2022-01-27 P030009-S104 Integrity Coronary Stent System 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2021-12-14 P030009-S105 Integrity Coronary Stent System RX and OTW 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2021-11-16 P030009-S106 Integrity Coronary Stent System Rx and OTW 30-Day Notice MAF Stent, Coronary Unknown
2021-05-21 P030009-S103 Integrity Coronary Stent System Rx and OTW Special (Immediate Track) MAF Stent, Coronary Unknown
2021-05-11 P030009-S102 Integrity Coronary Stent System (hereafter called Integrity) 30-Day Notice MAF Stent, Coronary Unknown
2021-03-12 P030009-S100 Integrity Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2021-02-23 P030009-S099 Integrity Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2020-10-30 P030009-S098 Integrity Rapid Exchange Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2020-10-05 P030009-S097 Integrity Coronary Stent System Normal 180 Day Track No User Fee MAF Stent, Coronary Unknown
2020-06-02 P030009-S096 Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-08-14 K261428 NC Euphora Rapid Exchange Balloon Dilatation Catheter LOX — —
2026-07-27 K261759 Euphora Rapid Exchange (RX) Balloon Dilatation Catheter LOX — —
2026-01-17 K251970 Sprinter Legend Rapid Exchange Balloon Dilatation Catheter LOX — —
2025-10-29 K252390 Telescope Guide Extension Catheter DQY — —
2025-06-11 K250787 Liberant Thrombectomy System QEW Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence