Product code DTW
- Device name
- Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4340
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015-05-08 |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | 2004-07-02 |
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Rocky Mountain Research, Inc. | 1999-11-10 |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Stoeckert Instrumente | 1996-02-22 |
| K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | 1993-05-20 |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-18 |
| K915337 | CAPIOX LEVEL ALARM | Terumo Medical Corp. | 1992-02-21 |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | 1990-05-22 |
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | 1990-05-09 |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | 1987-09-30 |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | 1986-05-30 |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | 1985-10-21 |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | 1984-12-27 |
| K831879 | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | 1983-07-26 |
| K823712 | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | 1983-02-07 |
| K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | 1982-10-18 |
| K781145 | MONITOR KITS, BLOOD LEVEL | 3M Health Care, Sarns | 1978-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850000067134 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 30695085000529 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 30695085000536 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 30695085000543 | Level 1 | ICU MEDICAL, INC. | 2016-10-14 |
| 20695085000522 | Level 1 | SMITHS MEDICAL MD, INC. | 2016-10-14 |
| 20695085000539 | Level 1 | SMITHS MEDICAL MD, INC. | 2016-10-14 |
| 10695085000549 | Level 1 | SMITHS MEDICAL MD, INC. | 2016-10-14 |
| 00886799000212 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000229 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000236 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000342 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799001721 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000199 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2015-09-24 |