FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K Number: K113227
·
Decision Dec 8, 2011
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
505
Review Days
37
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Basic Information
- Device Name
- NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
- K Number
- K113227
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- November 1, 2011
- Decision Date
- December 8, 2011
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
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