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K Number
K960169
Device Name
CARBOMEDICS VALVE TESTER
Manufacturer
CARBOMEDICS, INC.
Date Cleared
1996-04-15

(90 days)

Product Code
DTJ
Regulation Number
870.3935
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.3935 Prosthetic heart valve holder.

(a)
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.