FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Essenz HLM, Essenz ILBM
K Number: K232291
·
Decision Aug 24, 2023
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
51
Applicant Total
7
Review Days
23
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Basic Information
- Device Name
- Essenz HLM, Essenz ILBM
- K Number
- K232291
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Livanova Deutschland, GmbH
- Date Received
- August 1, 2023
- Decision Date
- August 24, 2023
- Product Code
- DTQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Livanova Deutschland, GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K221373 | Essenz HLM | Mar 9, 2023 | Substantially Equivalent |
| K220635 | Heater-Cooler System 3T | Nov 16, 2022 | Substantially Equivalent |
| K212003 | ESSENZ Patient Monitor | Nov 10, 2021 | Substantially Equivalent |
| K210130 | Stockert S5 System | Apr 5, 2021 | Substantially Equivalent |
| K202154 | B-Capta | Apr 1, 2021 | Substantially Equivalent |
| K191402 | Heater-Cooler System 3T | Feb 25, 2020 | Substantially Equivalent |