FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Heater-Cooler System 3T
K Number: K191402
·
Decision Feb 25, 2020
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
29
Applicant Total
7
Review Days
277
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Heater-Cooler System 3T
- K Number
- K191402
- 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
- May 24, 2019
- Decision Date
- February 25, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWC), ordered by most recent decision date.
Heater-Cooler System 3T
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Heater-Cooler
FDA 510(k)
FDA Class 2
·Cardiovascular
SORIN FLEXTHERM
FDA 510(k)
FDA Class 2
·Cardiovascular
HEATER-COOLER UNIT HCU 40
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |