DTJ · Class I · 21 CFR 870.3935

FDA Product Code DTJ: Holder, Heart-valve, Prosthesis

Leading manufacturers include Carbomedics, Inc., Shiley, Inc. and American Edwards Laboratories.

12
Total
12
Cleared
53d
Avg days
1979
Since

FDA 510(k) Cleared Holder, Heart-valve, Prosthesis Devices (Product Code DTJ)

12 devices
1–12 of 12
Cleared Aug 27, 1996
CARBOMEDICS HANDLE
K962154
Carbomedics, Inc.
Cardiovascular · 84d
Cleared Apr 15, 1996
CARBOMEDICS VALVE TESTER
K960169
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Jul 06, 1994
CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
K942736
Carbomedics, Inc.
Cardiovascular · 26d
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052
Baxter Healthcare Corp
Cardiovascular · 86d
Cleared Jun 15, 1987
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
K871596
Shiley, Inc.
Cardiovascular · 52d
Cleared Nov 20, 1986
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
K864155
American Edwards Laboratories
Cardiovascular · 28d
Cleared Dec 10, 1981
IONESCU-SHILEY VALVE HOLDER & HANDLE
K813276
Shiley, Inc.
Cardiovascular · 17d

About Product Code DTJ - Regulatory Context