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510(k) Data Aggregation
K Number
K962081Device Name
COMBILINES HEMODIALYSIS BLOOD TUBING SET
Manufacturer
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
Date Cleared
1996-11-01
(157 days)
Product Code
FJK
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
No new claims or indications are made.
Device Description
The proposed kit raises no new issues of safety or efficacy. In incorporating the components into a kit no modifications have been made which will affect safety or efficacy. Sterilization method and packaging are essentially the same.
The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided.
The integrity of the bonded connections of the bloodlines and of the connection of the transducer protectors to the monitor lines have been tested and data provided.
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K Number
K941757Device Name
FORMALIN REUSE CART
Manufacturer
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
Date Cleared
1996-01-22
(654 days)
Product Code
LIF
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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