FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Cathivex ¿GV filter units
K Number: K143583
·
Decision Aug 11, 2015
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
2
Review Days
236
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Basic Information
- Device Name
- Cathivex ¿GV filter units
- K Number
- K143583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merck Millipore , Ltd.
- Date Received
- December 18, 2014
- Decision Date
- August 11, 2015
- 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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Other Clearances by Merck Millipore , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K133004 | VENTED MILLEX -GV, CATHIVEX -GV | Mar 27, 2014 | Substantially Equivalent |