FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2008 HEMODIALYSIS SORBENT SYSTEM
K Number: K123835
·
Decision Feb 15, 2013
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
18
Applicant Total
9
Review Days
64
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Basic Information
- Device Name
- 2008 HEMODIALYSIS SORBENT SYSTEM
- K Number
- K123835
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5600
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renal Solutions, Inc.
- Date Received
- December 13, 2012
- Decision Date
- February 15, 2013
- Product Code
- FKT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKT | System, Dialysate Delivery, Sorbent Regenerated | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKT), ordered by most recent decision date.
2008 HEMODIALYSIS SORBENT SYSTEM
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ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
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ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
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ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
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SORB+HISORB+CARTRIDGE
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REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
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FDA Class 2
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Other Clearances by Renal Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121497 | VENOFER PUMP | Aug 17, 2012 | Substantially Equivalent |
| K103564 | VENOFER PUMP | Feb 10, 2011 | Substantially Equivalent |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Aug 13, 2010 | Substantially Equivalent |
| K093964 | VENOFER PUMP | Jul 9, 2010 | Substantially Equivalent |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | May 25, 2007 | Substantially Equivalent |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | May 24, 2006 | Substantially Equivalent |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Jun 3, 2005 | Substantially Equivalent |
| K031099 | SORB+HISORB+CARTRIDGE | Sep 17, 2003 | Substantially Equivalent |