Stockertir Purge Control (APC) System
510(k) K041558
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041558 | Date2 Jul 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DTW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stockertir Purge Control (APC) System is a Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass device, classified under FDA regulation 870.4340. It is designed to detect and remove air from the venous line and venous bubble trap of a cardiopulmonary bypass circuit, ensuring safe operation during perfusion procedures. This system is intended for use with compatible perfusion systems, such as the Stockert S3 Perfusion System, to maintain circuit integrity during short-duration bypass procedures (six hours or less).
The device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K041558) as a Class 2 Cardiovascular device. It operates within the context of cardiopulmonary bypass circuits, requiring proper integration with compatible perfusion systems. The system’s functionality relies on level sensing and air purge control mechanisms to mitigate risks associated with air emboli during surgical procedures. No specific sterility or MRI safety information is provided in the regulatory data.
Other devices from Stockert Instrumente GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Stockertir Purge Control (APC) System used for?
The Stockertir Purge Control (APC) System is designed to detect and eliminate air from the venous line and venous bubble trap within a cardiopulmonary bypass circuit. This prevents air emboli during perfusion procedures, ensuring safe operation when used with compatible systems like the Stockert S3 Perfusion System. It is specifically intended for short-duration bypass procedures (six hours or less).
Is the Stockertir Purge Control (APC) System reusable or single-use?
The Stockertir Purge Control (APC) System is supplied as a reusable medical instrument. It is not intended for single-use and must be properly maintained and integrated with compatible perfusion systems for repeated use in cardiopulmonary bypass procedures.
What types of perfusion systems is the APC System compatible with?
The Stockertir Purge Control (APC) System is designed to work with compatible perfusion systems, with explicit mention of the Stockert S3 Perfusion System in the regulatory documentation. It requires proper integration with these systems to function effectively during cardiopulmonary bypass procedures.
Does the Stockertir Purge Control (APC) System require sterilization?
The regulatory data for the Stockertir Purge Control (APC) System does not specify any sterility requirements. Since it is a reusable device, it must be cleaned and maintained according to manufacturer guidelines to ensure safe and effective use in clinical settings.
What regulatory pathway does the Stockertir Purge Control (APC) System follow?
The Stockertir Purge Control (APC) System is classified as a Class 2 Cardiovascular device under FDA regulation 870.4340 and has received FDA 510(k) clearance (K041558). It is substantially equivalent to predicate devices and was reviewed by the FDA’s Cardiovascular Advisory Committee.