DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass Class II
FDA product code DTW covers "Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4340. Submissions are reviewed by the Cardiovascular panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |