510(k) K182586 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 19, 2018 |
| Received | Sep 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Aortic Root Cannulae and Cardioplegia Needles:
a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009;
b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length Open, Classified |
DWF | None listed |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Cardioplegia Adapters:
a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 250 Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.