FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K Number: K141227
·
Decision Apr 2, 2015
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
9
Review Days
325
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Basic Information
- Device Name
- POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
- K Number
- K141227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sophysa SA
- Date Received
- May 12, 2014
- Decision Date
- April 2, 2015
- 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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Other Clearances by Sophysa SA
| K Number | Device Name | ||
|---|---|---|---|
| K162108 | Pressio 2 ICP Monitoring System | Apr 17, 2017 | Substantially Equivalent |
| K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | Jan 22, 2010 | Substantially Equivalent |
| K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | Aug 11, 2009 | Substantially Equivalent |
| K062584 | PRESSIO ICP MONITORING SYSTEM | Jul 5, 2007 | Substantially Equivalent |
| K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 | Dec 14, 2004 | Substantially Equivalent |
| K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB | Feb 26, 2004 | Substantially Equivalent |
| K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | Mar 27, 2002 | Substantially Equivalent |
| K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE | Sep 21, 2000 | Substantially Equivalent |