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Atrium Dry Suction Control Water Seal Chest Drain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K950677

by Atrium Medical Corp.

Identifiers

510(k) Number
K950677 FDA 510(k)
FDA Product Code
KDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6740 FDA 510(k)
Regulation Number
880.6740 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atrium Dry Suction Control Water Seal Chest Drain is a thoracic drainage system designed for the collection of fluids. It features a dry suction regulator, a graduated water seal, and a graduated air leak monitor to manage drainage.

This device is a single-use, disposable system with a 2100 ml collection volume. It is provided sterile and requires the addition of sterile fluid for operation. The device has received FDA 510k clearance.

Frequently asked questions

What is the primary function of the Atrium Dry Suction Control Water Seal Chest Drain?

This device is a thoracic drainage system specifically designed for the collection of fluids from the chest cavity. It utilizes a dry suction regulator, a graduated water seal, and a graduated air leak monitor to effectively manage and monitor the drainage process.

Is this chest drain intended for single-use or can it be reused?

The Atrium Dry Suction Control Water Seal Chest Drain is a single-use, disposable system. It is provided sterile to ensure patient safety and must be discarded after a single application to prevent cross-contamination.

What is the fluid collection capacity of this system?

This thoracic drainage system features a total collection volume of 2100 ml. It requires the addition of sterile fluid by the clinician to establish the water seal and ensure proper operation of the drainage system.

What is the regulatory status of this device?

The Atrium Dry Suction Control Water Seal Chest Drain has received FDA 510k clearance under K950677. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

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: Atrium Oasis Dry Suction Water Seal Chest Drain - Getinge, Atrium Dry Suction Water Seal Chest Drainage User guide - Manualzz, ATRIUM OASIS INSTRUCTIONS FOR USE Pdf Download | ManualsLib, Instructions for use Atrium Oasis Chest Drain Single Collection Dry ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrium Medical Corp.

Sources (1)

  • FDA 510(k) K950677 24 fields · synced Sep 24, 2026