DTI · Class I · 21 CFR 870.3945

FDA Product Code DTI: Sizer, Heart-valve, Prosthesis

Leading manufacturers include Carbomedics, Inc., Celtech and Medtronic Vascular.

7
Total
7
Cleared
90d
Avg days
1980
Since

FDA 510(k) Cleared Sizer, Heart-valve, Prosthesis Devices (Product Code DTI)

7 devices
1–7 of 7
Cleared Nov 29, 1995
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
K952184
Carbomedics, Inc.
Cardiovascular · 204d
Cleared Dec 10, 1993
VALVE SIZER
K934951
Carbomedics, Inc.
Cardiovascular · 53d
Cleared May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
K881279
Baxter Healthcare Corp
Cardiovascular · 57d
Cleared Nov 01, 1985
DUROMEDICS CARDIAC VALVE SIZER SET
K853313
Hemex Scientific, Inc.
Cardiovascular · 86d
Cleared Sep 23, 1985
METRONIC MODEL F7700 HEART VALVE SIZERS
K852612
Medtronic Vascular
Cardiovascular · 96d
Cleared Jul 08, 1982
MITRAL VALVE ORIFICE SIZER
K820887
Celtech
Cardiovascular · 100d
Cleared Sep 09, 1980
HANCOCK * OBTURATORS
K801885
Hancock Laboratories, Inc.
Cardiovascular · 33d

About Product Code DTI - Regulatory Context