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510(k) Data Aggregation
K Number
K051084Device Name
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
Manufacturer
DENVER BIOMEDICALS, INC.
Date Cleared
2005-06-13
(46 days)
Product Code
DWM
Regulation Number
870.5050Why did this record match?
Applicant Name (Manufacturer) :
DENVER BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
Device Description
The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
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K Number
K011020Device Name
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
Manufacturer
DENVER BIOMEDICALS, INC.
Date Cleared
2001-06-01
(58 days)
Product Code
KPM
Regulation Number
876.5955Why did this record match?
Applicant Name (Manufacturer) :
DENVER BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010642Device Name
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
Manufacturer
DENVER BIOMEDICALS, INC.
Date Cleared
2001-03-20
(15 days)
Product Code
DWM
Regulation Number
870.5050Why did this record match?
Applicant Name (Manufacturer) :
DENVER BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003451Device Name
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
Manufacturer
DENVER BIOMEDICALS, INC.
Date Cleared
2001-01-02
(56 days)
Product Code
KPM
Regulation Number
876.5955Why did this record match?
Applicant Name (Manufacturer) :
DENVER BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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