FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
K Number: K160223
·
Decision Apr 8, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
175
Review Days
70
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Basic Information
- Device Name
- VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
- K Number
- K160223
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- January 29, 2016
- Decision Date
- April 8, 2016
- Product Code
- NHC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NHC | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHC), ordered by most recent decision date.
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
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