FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMBOPERITONEAL SHUNT SYSTEM
K Number: K002476
·
Decision Nov 9, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
63
Same Product Code
252
Applicant Total
12
Review Days
90
Basic Information
- Device Name
- LUMBOPERITONEAL SHUNT SYSTEM
- K Number
- K002476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PHOENIX BIOMEDICAL CORP.
- Date Received
- August 11, 2000
- Decision Date
- November 9, 2000
- 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 |
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| K Number | Device Name | ||
|---|---|---|---|
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| K962144 | PHOENIX ETE TISSUE EXTENSION SYSTEM | Jan 14, 1997 | Substantially Equivalent |
| K960435 | PHOENIX CRX VALVE | Aug 27, 1996 | Substantially Equivalent |