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DTI — Sizer, Heart-Valve, Prosthesis Class I

FDA Device Classification

Classification Details

Product Code
DTI
Device Class
Class I
Regulation Number
870.3945
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952184carbomedicsCARBOMEDICS SUPRA-ANNULAR VALVE SIZERNovember 29, 1995
K934951carbomedicsVALVE SIZERDecember 10, 1993
K881279baxter healthcareEDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETMay 18, 1988
K853313hemex scientificDUROMEDICS CARDIAC VALVE SIZER SETNovember 1, 1985
K852612medtronic vascularMETRONIC MODEL F7700 HEART VALVE SIZERSSeptember 23, 1985
K820887celtechMITRAL VALVE ORIFICE SIZERJuly 8, 1982
K801885hancock laboratoriesHANCOCK * OBTURATORSSeptember 9, 1980