Product code DTW— Cardiovascular
BEL BLOOD LEVEL DETECTOR
- Classification name
- Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4340
- Advisory panel
- Cardiovascular
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code DTW
FDA has cleared devices under product code DTW between 1978 and 2015, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2004
- 1999
- 1996
- 1993
- 1992
- 1990
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1978
Top applicants under product code DTW
Recent clearances under product code DTW
- K150530 — Level Sensor, Level Sensor Tape
- K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM
- K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
- K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
- K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR
- K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
- K915337 — CAPIOX LEVEL ALARM
- K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
- K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
- K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
- K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
- K852407 — SENSOR TAPE CAT. NO. ST-45
- K843802 — STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
- K831879 — UNIVERSAL LEVEL SENSOR
- K823712 — BEL BLOOD LEVEL DETECTOR
- K822821 — GAMBRO BLOOD LEVEL DETECTOR LCS 10
- K781145 — MONITOR KITS, BLOOD LEVEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.