Panels › Cardiovascular › Product code DXS · Class 2
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Regulation 870.4310
0510(k)s in 12 months (13 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in DXS
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Perfusion Systems | 0 | 5 |
| Delta Medical Industries | 3 | 0 |
| Shiley, Inc. | 2 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| American Omni Medical, Inc. | 1 | 0 |
| Dlp, Inc. | 1 | 0 |
| Gambro, Inc. | 1 | 0 |
| Lifestream Int'L, Inc. | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Norton Texas Medical Products | 1 | 0 |
| 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 | K113235 |
| 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 | K852232 |
| 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 | K852232 |
| 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 | K852232 |
| 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 | K852232 |
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