FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
K Number: K111702
·
Decision Mar 22, 2012
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
3
Review Days
279
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Basic Information
- Device Name
- AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
- K Number
- K111702
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fenwal, Inc.
- Date Received
- June 17, 2011
- Decision Date
- March 22, 2012
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
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