510(k) K113235 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Dec 2, 2011 |
| Received | Nov 2, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Disposable Pressure Display Sets:
a) DLP 114.3 cm (45 in), Model Number 61000;
b) DLP 114.3 cm (45 in), Model Number 62000 Open, Classified |
DXS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.