FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
K Number: K071640
·
Decision Jul 12, 2007
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
190
Review Days
27
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Basic Information
- Device Name
- VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
- K Number
- K071640
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- June 15, 2007
- Decision Date
- July 12, 2007
- 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 Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
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