Panels › Cardiovascular › Product code DTW · Class 2
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation 870.4340
0510(k)s in 12 months (17 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in DTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Terumo Cardiovascular Systems Corp | 0 | 15 |
| 3M Health Care, Sarns | 2 | 0 |
| Gambro, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| American Omni Medical, Inc. | 1 | 0 |
| Cobe Laboratories, Inc. | 1 | 0 |
| Jtl Medical Corp. | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| R. Scott Bell | 1 | 0 |
| Respiratory Support Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2015 | K150530 | Level Sensor, Level Sensor Tape Medtronic, Inc. | DTW |
| Jul 2, 2004 | K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM Stockert Instrumente GmbH | DTW |
| Nov 10, 1999 | K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 Rocky Mountain Research, Inc. | DTW |
| Feb 22, 1996 | K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER Stoeckert Instrumente | DTW |
| May 20, 1993 | K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR Jtl Medical Corp. | DTW |
| Feb 18, 1993 | K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR Sorin Biomedica, Fiat, USA, Inc. | DTW |
| Feb 21, 1992 | K915337 | CAPIOX LEVEL ALARM Terumo Medical Corp. | DTW |
| May 22, 1990 | K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) Cobe Laboratories, Inc. | DTW |
| May 9, 1990 | K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL 3M Company | DTW |
| Sep 30, 1987 | K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE Respiratory Support Products, Inc. | DTW |
| May 30, 1986 | K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 Gambro, Inc. | DTW |
| Oct 21, 1985 | K852407 | SENSOR TAPE CAT. NO. ST-45 American Omni Medical, Inc. | DTW |
| Dec 27, 1984 | K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR Shiley, Inc. | DTW |
| Jul 26, 1983 | K831879 | UNIVERSAL LEVEL SENSOR 3M Health Care, Sarns | DTW |
| Feb 7, 1983 | K823712 | BEL BLOOD LEVEL DETECTOR R. Scott Bell | DTW |
| Oct 18, 1982 | K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 Gambro, Inc. | DTW |
| Jul 27, 1978 | K781145 | MONITOR KITS, BLOOD LEVEL 3M Health Care, Sarns | DTW |
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