510(k) K852232 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
| Applicant | Dlp, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Aug 9, 1985 |
| Received | May 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | Medtronic Perfusion Systems DLP Pressure Disposable Pressure Display Sets
Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery. Terminated |
DXS | None listed |
| Oct 20, 2011 | Medtronic Perfusion Systems Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/ Terminated |
DXS | None listed |
| Oct 20, 2011 | Medtronic Perfusion Systems Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone di Terminated |
DXS | None listed |
| Oct 20, 2011 | Medtronic Perfusion Systems Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufactur Terminated |
DXS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.