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K Number
K010642

Validate with FDA (Live)

Device Name
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
Manufacturer
DENVER BIOMEDICALS, INC.
Date Cleared
2001-03-20

(15 days)

Product Code
DWM
Regulation Number
870.5050
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K071095,K093307
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.5050 Patient care suction apparatus.

(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).