Stockert Caps Low Level Detect Ii/Bubble Monitor
FDA 510(k) K924354 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK924354
Submission
- Device name
- Stockert Caps Low Level Detect Ii/Bubble Monitor
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Irvine, CA, US - Received
- August 12, 1992
- Decision date
- February 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4340
- Specialty
- Cardiovascular
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| K150530 | Level Sensor, Level Sensor TapeDTW · Special | Medtronic, Inc. | 05/08/2015SE |
| K041558 | Stockertir Purge Control (Apc) SystemDTW · Special | Stockert Instrumente GmbH | 07/02/2004SE |
| K992857 | Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070DTW · Traditional | Rocky Mountain Research, Inc. | 11/10/1999SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | Stoeckert Instrumente | 02/22/1996SE |
| K910599 | Cardiopulmonary Bypass Level Sensing MonitorDTW · Traditional | Jtl Medical Corp. | 05/20/1993SE |
| K915337 | Capiox Level AlarmDTW · Traditional | Terumo Medical Corp. | 02/21/1992SE |
| K900910 | Cobe Air Emboli Protection System (Aeps)DTW · Traditional | Cobe Laboratories, Inc. | 05/22/1990SE |
| K900815 | Sarns 9000 Perfusion System W/Alert Only LevelDTW · Traditional | 3M Company | 05/09/1990SE |
| K873206 | Myocardial Temp. Sensor W/Type T ThermocoupleDTW · Traditional | Respiratory Support Products, Inc. | 09/30/1987SE |
| K860076 | Gambro Ultrasonic Blood Level Detector Uld 10-200DTW · Traditional | Gambro, Inc. | 05/30/1986SE |
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| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
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| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | 03/26/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | 02/02/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | 11/30/1992SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K852641 | Orion 40 Cardiac Stimulator & PMP 200 ProgrammerDXY · Traditional | 01/14/1986SE |
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Questions and answers
When was Stockert Caps Low Level Detect Ii/Bubble Monitor cleared by the FDA?
Stockert Caps Low Level Detect Ii/Bubble Monitor (K924354) received a 510(k) decision of Substantially Equivalent on February 18, 1993, 190 days after the submission was received.
What is the product code of K924354?
The FDA product code is DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4340.