Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Su…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201305 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Auto Transfusion Chest Drains are classified as Apparatus, Autotransfusion under FDA nomenclature. These devices are designed to facilitate the drainage of air, blood, or other fluids from the pleural space, aiding in the management of conditions such as pneumothorax, hemothorax, or post-surgical drainage. They incorporate features such as water seal and dry suction mechanisms to ensure effective evacuation and prevent re-expansion of collapsed lung tissue.
These drains are intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Supplied as single-use devices, they require sterile handling and proper disposal after use. The Ocean Water Seal, Oasis Dry Suction Water Seal, and Express Dry Seal variants are regulated under FDA 510(k) clearance (K201305) and fall under device classification II. Each variant is designed for specific drainage applications, adhering to regulatory standards for medical devices in the United States.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201305 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corporation
Sources (1)
- FDA 510(k) K201305 24 fields · synced Sep 18, 2026