FDA 510(k) Applications for Medical Device Product Code "DTI"
(Sizer, Heart-Valve, Prosthesis)

FDA 510(k) Number Applicant Device Name Decision Date
K881279 BAXTER HEALTHCARE CORP. EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET 05/18/1988
K952184 CARBOMEDICS, INC. CARBOMEDICS SUPRA-ANNULAR VALVE SIZER 11/29/1995
K934951 CARBOMEDICS, INC. VALVE SIZER 12/10/1993
K820887 CELTECH MITRAL VALVE ORIFICE SIZER 07/08/1982
K801885 HANCOCK LABORATORIES, INC. HANCOCK * OBTURATORS 09/09/1980
K853313 HEMEX SCIENTIFIC, INC. DUROMEDICS CARDIAC VALVE SIZER SET 11/01/1985
K852612 MEDTRONIC VASCULAR METRONIC MODEL F7700 HEART VALVE SIZERS 09/23/1985


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