FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
K Number: K894721
·
Decision Oct 20, 1989
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
4
Review Days
87
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Basic Information
- Device Name
- TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
- K Number
- K894721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- The Traumafuse Co.
- Date Received
- July 25, 1989
- Decision Date
- October 20, 1989
- Product Code
- DWE
- 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 |
|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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