DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DTW
- Device Class
- Class II
- Regulation Number
- 870.4340
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K150530 | medtronic | Level Sensor, Level Sensor Tape | May 8, 2015 |
| K041558 | stockert instrumente | STOCKERTIR PURGE CONTROL (APC) SYSTEM | July 2, 2004 |
| K992857 | rocky mountain research | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | November 10, 1999 |
| K955152 | stoeckert instrumente | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | February 22, 1996 |
| K910599 | jtl medical | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | May 20, 1993 |
| K924354 | sorin biomedica, fiat, usa | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | February 18, 1993 |
| K915337 | terumo medical | CAPIOX LEVEL ALARM | February 21, 1992 |
| K900910 | cobe laboratories | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | May 22, 1990 |
| K900815 | 3m | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | May 9, 1990 |
| K873206 | respiratory support products | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | September 30, 1987 |
| K860076 | gambro | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | May 30, 1986 |
| K852407 | american omni medical | SENSOR TAPE CAT. NO. ST-45 | October 21, 1985 |
| K843802 | shiley | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | December 27, 1984 |
| K831879 | 3m health care, sarns | UNIVERSAL LEVEL SENSOR | July 26, 1983 |
| K823712 | r. scott bell | BEL BLOOD LEVEL DETECTOR | February 7, 1983 |
| K822821 | gambro | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | October 18, 1982 |
| K781145 | 3m health care, sarns | MONITOR KITS, BLOOD LEVEL | July 27, 1978 |