FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CSF400 AND CSF600
K Number: K030081
·
Decision Oct 6, 2003
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
3
Review Days
270
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CSF400 AND CSF600
- K Number
- K030081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inmed Ltda.
- Date Received
- January 9, 2003
- Decision Date
- October 6, 2003
- Product Code
- JXG
- 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXG), ordered by most recent decision date.
Intellidrop
FDA 510(k)
FDA Class 2
·Neurology
Sophy Mini Monopressure Valve (SM1)
FDA 510(k)
FDA Class 2
·Neurology
EVAC-MRI
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
FDA 510(k)
FDA Class 2
·Neurology
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
FDA 510(k)
FDA Class 2
·Neurology