Identifiers
- 510(k) Number
- K130210 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medela Thopaz is a portable, powered aspiration pump designed for chest drainage. It is classified as a manual or powered aspiration pump and is intended for mediastinal and pleural drainage, particularly in post-cardiac and thoracic surgical settings. The device helps manage fluid accumulation in the chest cavity, reducing complications associated with drainage procedures.
The Medela Thopaz is supplied as a reusable medical device and is intended for use in clinical environments such as operating rooms and intensive care units. It operates under sterile conditions and is compatible with MRI environments, as indicated by its regulatory classification. The device is authorized under an FDA 510(k) clearance (K130210) and falls under the product code BTA, regulated under 878.4780. It is designed for single-patient use per session, with specific models and sizes tailored for various drainage applications.
Frequently asked questions
What is the Medela Thopaz used for?
The Medela Thopaz is designed specifically for chest drainage, helping manage fluid accumulation in the mediastinal and pleural cavities. This is particularly important in post-cardiac and thoracic surgical settings, where fluid buildup can lead to complications. By effectively removing excess fluid, the device supports recovery and reduces risks associated with drainage procedures.
Is the Medela Thopaz reusable or single-use?
The Medela Thopaz is a reusable medical device, intended for use in clinical environments like operating rooms and intensive care units. While the device itself is reusable, it is designed for single-patient use per session to maintain sterility and hygiene standards. This ensures safe and consistent performance across multiple procedures.
What sizes or models of the Medela Thopaz are available?
The Medela Thopaz comes in multiple models and sizes, each tailored to different drainage applications. These variations allow clinicians to select the appropriate configuration based on patient needs, ensuring optimal performance for mediastinal and pleural drainage. The exact specifications can be referenced in the device documentation or through Medela’s technical support.
Can the Medela Thopaz be used in an MRI environment?
Yes, the Medela Thopaz is compatible with MRI environments. This feature is particularly useful in clinical settings where patients may require both drainage and MRI imaging, as it ensures the device can be safely used without interference or safety concerns related to magnetic fields.
How should the Medela Thopaz be stored?
The Medela Thopaz should be stored in a clean, dry environment to maintain its functionality and sterility. Since it is a reusable device, proper cleaning and maintenance procedures must be followed after each use to prevent contamination and ensure longevity. Follow the manufacturer’s guidelines for storage and disinfection to uphold clinical standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Thopaz+ after Cardiac Surgery - Medela, Thopaz+ after thoracic surgery and interventions - Medela, MEDELA THOPAZ INSTRUCTIONS FOR USE MANUAL Pdf Download, MEDELA THOPAZ+ INSTRUCTIONS FOR USE MANUAL Pdf Download, Medela Thopaz - Operating instructions, Quick Reference ... - manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130210 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela AG
Sources (1)
- FDA 510(k) K130210 24 fields · synced Oct 1, 2026