FDA Product Code DTQ: Console, Heart-lung Machine, Cardiopulmonary Bypass
Leading manufacturers include Livanova Deutschland, GmbH, Spectrum Medical , Ltd. and Century Hlm, LLC.
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
Cleared
Mar 09, 2023
Essenz HLM
Livanova Deutschland, GmbH
Cardiovascular
301d
Cleared
Apr 05, 2021
Stockert S5 System
Livanova Deutschland, GmbH
Cardiovascular
76d
Cleared
Mar 07, 2021
Century Perfusion System
Century Hlm, LLC
Cardiovascular
219d
Cleared
May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Spectrum Medical , Ltd.
Cardiovascular
102d
Cleared
May 25, 2018
Quantum Pump Console
Spectrum Medical , Ltd.
Cardiovascular
158d
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.