Search Results
Found 1 results
510(k) Data Aggregation
K Number
K062302Device Name
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
Manufacturer
MILLICORE AB
Date Cleared
2006-10-06
(59 days)
Product Code
KDQ, KDO
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
MILLICORE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.
Device Description
The DigiVent™ Chest Drainage System consists primarily of a collection chamber and a Controller Unit. Pressure regulator, drainage tubing (with kink prevention), positive- and negative pressure relief valves, and hangers complete the system. Thoracic catheters (chest tubes) are not included.
Ask a Question
Page 1 of 1