FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Heater-Cooler System 3T
K Number: K220635
·
Decision Nov 16, 2022
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
29
Applicant Total
7
Review Days
257
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Basic Information
- Device Name
- Heater-Cooler System 3T
- K Number
- K220635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Livanova Deutschland, GmbH
- Date Received
- March 4, 2022
- Decision Date
- November 16, 2022
- Product Code
- DWC
- 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 |
|---|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Livanova Deutschland, GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Aug 24, 2023 | Substantially Equivalent |
| K221373 | Essenz HLM | Mar 9, 2023 | 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 |