FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRIMED SYSTEM 1
K Number: K842007
·
Decision Aug 3, 1984
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
4
Review Days
78
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
- CENTRIMED SYSTEM 1
- K Number
- K842007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Centrimed Corp.
- Date Received
- May 17, 1984
- Decision Date
- August 3, 1984
- Product Code
- KFM
- 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 |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFM), ordered by most recent decision date.
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
FDA 510(k)
FDA Class 2
·Cardiovascular
LifeSPARC System
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Capiox iCP Centrifugal Pump
FDA 510(k)
FDA Class 2
·Cardiovascular