DTW · Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4340 · Class 2
Overview
| Product Code | DTW |
|---|---|
| Device Name | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | May 8, 2015 | SESE |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | Jul 2, 2004 | SESE |
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Rocky Mountain Research, Inc. | Nov 10, 1999 | SESE |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Stoeckert Instrumente | Feb 22, 1996 | SESE |
| K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | May 20, 1993 | SESE |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | Feb 18, 1993 | SESE |
| K915337 | CAPIOX LEVEL ALARM | Terumo Medical Corp. | Feb 21, 1992 | SESE |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | May 22, 1990 | SESE |
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | May 9, 1990 | SESE |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | Sep 30, 1987 | SESE |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | May 30, 1986 | SESE |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | Oct 21, 1985 | SESE |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | Dec 27, 1984 | SESE |
| K831879 | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | Jul 26, 1983 | SESE |
| K823712 | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | Feb 7, 1983 | SESE |
| K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| K781145 | MONITOR KITS, BLOOD LEVEL | 3M Health Care, Sarns | Jul 27, 1978 | SESE |
Top Applicants
- Gambro, Inc. — 2 clearances
- 3M Health Care, Sarns — 2 clearances
- Terumo Medical Corp. — 1 clearance
- Stoeckert Instrumente — 1 clearance
- Stockert Instrumente GmbH — 1 clearance
