FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K Number: K132905
·
Decision Oct 4, 2013
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
1
Review Days
18
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Basic Information
- Device Name
- 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
- K Number
- K132905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arteriocyte Medical Systems, Inc.
- Date Received
- September 16, 2013
- Decision Date
- October 4, 2013
- Product Code
- BRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BRZ | Set, Blood Transfusion | FDA class 2 | General Hospital |
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