FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K Number: K982822
·
Decision Sep 30, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
505
Review Days
50
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Basic Information
- Device Name
- FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- K Number
- K982822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- August 11, 1998
- Decision Date
- September 30, 1998
- Product Code
- CAK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | FDA class 2 | General Hospital |
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