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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2011 | K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS Medtronic, Inc. | DXS |
| Dec 27, 1994 | K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET Vascular Technology Incorporated | DXS |
| Oct 31, 1991 | K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST Lifestream Int'L, Inc. | DXS |
| May 10, 1990 | K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR Shiley, Inc. | DXS |
| Nov 6, 1987 | K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 American Omni Medical, Inc. | DXS |
| Sep 12, 1986 | K862836 | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE Shiley, Inc. | DXS |
| Aug 9, 1985 | K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 Dlp, Inc. | DXS |
| Aug 27, 1984 | K842194 | PRESSURE MONITOR Norton Texas Medical Products | DXS |
| Jul 26, 1983 | K831750 | PM-3 Delta Medical Industries | DXS |
| Oct 18, 1982 | K822822 | GAMBRO PRESSURE MONITOR PRM 10 Gambro, Inc. | DXS |
| May 18, 1982 | K820912 | PMS-2 PRESSURE MONITOR SEPARATOR Delta Medical Industries | DXS |
| Dec 4, 1978 | K781890 | CHAMBER, MC-1 DISPOSABLE PRESSURE Delta Medical Industries | DXS |
| Sep 30, 1977 | K771764 | CORONARY PRESSURE PERFUSION PUMP 3M Health Care, Sarns | DXS |
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