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510(k) Data Aggregation
K Number
K962154Device Name
CARBOMEDICS HANDLE
Manufacturer
CARBOMEDICS, INC.
Date Cleared
1996-08-27
(84 days)
Product Code
DTJ
Regulation Number
870.3935Why did this record match?
Product Code :
DTJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reusable CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.
Device Description
The reusable CarboMedics Handle is a one-piece, injection molded handle and is provided in one size only. The CarboMedics Handle consists of a threaded polysulfone tip injection molded to a bendable handle. The reusable CarboMedics Handle is manufactured using a polysulfone injection molding process. The CarboMedics Handle consists of a white polysulfone threaded tip injection molded onto a bendable stainless steel shaft, injection molded to a white polysulfone handle. It is supplied non-sterile and must be cleaned and sterilized prior to initial use and each reuse.
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K Number
K960169Device Name
CARBOMEDICS VALVE TESTER
Manufacturer
CARBOMEDICS, INC.
Date Cleared
1996-04-15
(90 days)
Product Code
DTJ
Regulation Number
870.3935Why did this record match?
Product Code :
DTJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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