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510(k) Data Aggregation
K Number
K974475Device Name
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
Manufacturer
Date Cleared
1998-03-02
(96 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
BIOCONTROL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The theraPORT Low-Profile Vascular Access System is a totally implantable venous access system intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling. Because of its low-profile design, it is indicated for either traditional chest placement or placement in the upper arm, and is appropriate for use in pediatric patients and small adults.
Device Description
The theraPORT® Low-Profile Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
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K Number
K960350Device Name
THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602
Manufacturer
Date Cleared
1996-04-15
(81 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
BIOCONTROL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.
Device Description
The theraPORT® Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
Ask a Question
Ask a specific question about this device
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