Coopdech Endobronchial Blocker Tube
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093888 FDA 510(k)
- FDA Product Code
- CBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5740 FDA 510(k)
- Regulation Number
- 868.5740 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Coopdech Endobronchial Blocker Tube is a tracheal/bronchial tube designed for differential ventilation, enabling selective lung isolation. It features a specialized blocker lumen to occlude one bronchus while allowing ventilation of the other, facilitating one-lung ventilation during surgical procedures such as thoracotomy or lung resection.
This device is supplied as a single-use, non-sterile product and is intended for use in operating rooms by trained anesthesiologists. It is classified as a Class II medical device under the FDA and has received 510(k) clearance. The tube is available in multiple models (e.g., Bbt-a30xxx, Bbt-b30xxx) and must be inspected for integrity prior to use. Storage should follow manufacturer guidelines to maintain functionality.
Frequently asked questions
What is the primary purpose of the Coopdech Endobronchial Blocker Tube and how does it differ from standard tracheal tubes?
The Coopdech Endobronchial Blocker Tube is specifically designed for differential ventilation, allowing selective lung isolation during procedures like thoracotomy or lung resection. Unlike standard tracheal tubes, it features a specialized blocker lumen that can occlude one bronchus while permitting ventilation of the other, enabling one-lung ventilation. This makes it ideal for surgical cases requiring isolated lung function.
Is the Coopdech Endobronchial Blocker Tube intended for reuse, or is it meant for single-use only?
The device is explicitly labeled as a single-use product. It is not designed for reuse, and proper disposal after one use is required to maintain safety and sterility standards. This classification aligns with its non-sterile packaging as noted in the manufacturer’s instructions.
How should the Coopdech Endobronchial Blocker Tube be stored, and what precautions should be taken before use?
Storage must follow the manufacturer’s guidelines to preserve functionality. Since it is non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, the tube must be inspected for integrity to ensure no damage or defects exist, as recommended in the device’s instructions.
What models of the Coopdech Endobronchial Blocker Tube are available, and how do they differ?
The device is available in multiple models, including Bbt-a30xxx and Bbt-b30xxx series. While exact differences between models aren’t specified, the numbering suggests variations in size, lumen configuration, or other technical specifications tailored for different patient anatomies or clinical needs. Referencing the manufacturer’s documentation will clarify specific model distinctions.
Who is the intended user of the Coopdech Endobronchial Blocker Tube, and where is it primarily used?
The device is intended for use in operating rooms by trained anesthesiologists. Its specialized design for differential ventilation makes it suitable for complex procedures like thoracotomy or lung resection, where precise lung isolation is critical. It is not intended for general anesthesia or non-surgical settings.
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: COOPDECH Endobronchial Blocker Tube | PRODUCT LIST | COOPDECH, Daiken ..., COOPDECH ENDOBRONCHIAL BLOCKER TUBE - Innolitics, Coopdech Endobronchial Blocker Tube, Models Bbt-a30xxx, Bbt-b30xxx
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093888 | Class II | Active |
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Manufacturer
- Manufacturer
- Daiken Medical Co., Ltd.
- FDA Applicant
- Daiken Medical Co, Ltd.
Sources (1)
- FDA 510(k) K093888 24 fields · synced Sep 19, 2026