Essenz HLM
FDA 510(k) K221373 · Livanova Deutschland, GmbH
510(k) numberK221373
Submission
- Device name
- Essenz HLM
- Applicant
- Livanova Deutschland, GmbH
Munich, DE - Received
- May 12, 2022
- Decision date
- March 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | Livanova Deutschland, GmbH | 08/24/2023SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | Spectrum Medical , Ltd. | 05/24/2019SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
| K151349 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 08/27/2015SE |
More from Terumo Cardiovascular Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | 08/24/2023SE |
| K220635 | Heater-Cooler System 3TDWC · Traditional | 11/16/2022SE |
| K212003 | ESSENZ Patient MonitorDXJ · Special | 11/10/2021SE |
| K210130 | Stockert S5 SystemDTQ · Special | 04/05/2021SE |
| K202154 | B-CaptaDRY · Traditional | 04/01/2021SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | 02/25/2020SE |
Questions and answers
When was Essenz HLM cleared by the FDA?
Essenz HLM (K221373) received a 510(k) decision of Substantially Equivalent on March 9, 2023, 301 days after the submission was received.
What is the product code of K221373?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.