FDA Product Code DTQ: Console, Heart-lung Machine, Cardiopulmonary Bypass
Leading manufacturers include Terumo Cardiovascular Systems Corporation and Livanova Deutschland, GmbH.
52
Total
52
Cleared
125d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Console, Heart-lung Machine, Cardiopulmonary Bypass Devices (Product Code DTQ)
52 devices
Cleared
Aug 24, 2023
Essenz HLM, Essenz ILBM
Livanova Deutschland, GmbH
Cardiovascular
23d
Cleared
Apr 18, 2023
Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
Cardiovascular
292d
About Product Code DTQ - Regulatory Context
510(k) Submission Activity
52 total 510(k) submissions under product code DTQ since 1977, with 52 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
DTQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →