Stockertir Purge Control (Apc) System
FDA 510(k) K041558 · Stockert Instrumente GmbH
510(k) numberK041558
Submission
- Device name
- Stockertir Purge Control (Apc) System
- Applicant
- Stockert Instrumente GmbH
North Attleboro, MA, US - Received
- June 10, 2004
- Decision date
- July 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/18/1993SE |
| 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 |
More from Gambro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042374 | Stockert SCP RhythmDWA · Special | 09/23/2004SE |
| K032213 | Stockert Centrifugal Pump System with Tubing ClampDWA · Traditional | 08/29/2003SE |
| K023622 | Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35DWF · Abbreviated | 11/21/2002SE |
| K022280 | Stockert Coronary Perfusion CannulaeDWF · Abbreviated | 10/11/2002SE |
| K022321 | Stockert V172-28 Venous Femoral CannulaDWF · Traditional | 10/09/2002SE |
| K020571 | Stockert Centrifugal Pump ConsoleDTQ · Traditional | 09/23/2002SE |
| K011838 | Centrifugal PumpDWA · Traditional | 02/05/2002SE |
| K011088 | Siii Alarm AmplifierDTQ · Special | 05/02/2001SE |
Questions and answers
When was Stockertir Purge Control (Apc) System cleared by the FDA?
Stockertir Purge Control (Apc) System (K041558) received a 510(k) decision of Substantially Equivalent on July 2, 2004, 22 days after the submission was received.
What is the product code of K041558?
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.