Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
The Level Sensing Monitor and Control for Cardiopulmonary Bypass is a cardiovascular safety device used to detect and control the blood level within the venous reservoir of a bypass circuit, preventing air entrainment and protecting the patient from air embolism during surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTW and it is regulated under 21 CFR 870.4340 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DTW
- Device Class
- FDA class 2
- Regulation Number
- 870.4340
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | May 08, 2015 | Substantially Equivalent | Medtronic, Inc. |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Jul 02, 2004 | Substantially Equivalent | Stockert Instrumente GmbH |
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Nov 10, 1999 | Substantially Equivalent | Rocky Mountain Research, Inc. |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Feb 22, 1996 | Substantially Equivalent | Stoeckert Instrumente |
| K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | May 20, 1993 | Substantially Equivalent | Jtl Medical Corp. |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Feb 18, 1993 | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. |
| K915337 | CAPIOX LEVEL ALARM | Feb 21, 1992 | Substantially Equivalent | Terumo Medical Corp. |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | May 22, 1990 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | May 09, 1990 | Substantially Equivalent | 3M Company |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Sep 30, 1987 | Substantially Equivalent | Respiratory Support Products, Inc. |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | May 30, 1986 | Substantially Equivalent | Gambro, Inc. |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | Oct 21, 1985 | Substantially Equivalent | American Omni Medical, Inc. |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Dec 27, 1984 | Substantially Equivalent | Shiley, Inc. |
| K831879 | UNIVERSAL LEVEL SENSOR | Jul 26, 1983 | Substantially Equivalent | 3M Health Care, Sarns |
| K823712 | BEL BLOOD LEVEL DETECTOR | Feb 07, 1983 | Substantially Equivalent | R. Scott Bell |
| K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Oct 18, 1982 | Substantially Equivalent | Gambro, Inc. |
| K781145 | MONITOR KITS, BLOOD LEVEL | Jul 27, 1978 | Substantially Equivalent | 3M Health Care, Sarns |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.