DTP · Class II · 21 CFR 870.4230

FDA Product Code DTP: Defoamer, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc., Scimed Life Systems, Inc. and Medtronic Vascular.

34
Total
34
Cleared
81d
Avg days
1980
Since
34 devices
25–34 of 34
Cleared Apr 24, 1984
SCIMED MODEL SC4000
K840610
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Sep 20, 1983
SHILEY 3L CARDF PLUS
K832811
Shiley, Inc.
Cardiovascular · 33d
Cleared Jan 05, 1983
CARDF
K823731
Shiley, Inc.
Cardiovascular · 26d
Cleared Aug 06, 1982
CAPIOX CR-CARDIOTOMY RESERVOIR
K821538
Terumo Medical Corp.
Cardiovascular · 74d
Cleared May 24, 1982
SCIMED MODEL SC 3000
K820954
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Jul 14, 1980
CARDIOTOMY RESERVOIR WITH FILTER
K801360
Travenol Laboratories, S.A.
Cardiovascular · 35d
Cleared Jul 14, 1980
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K801375
Shiley, Inc.
Cardiovascular · 33d