FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENOFER PUMP
K Number: K103564
·
Decision Feb 10, 2011
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
9
Review Days
66
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Basic Information
- Device Name
- VENOFER PUMP
- K Number
- K103564
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renal Solutions, Inc.
- Date Received
- December 6, 2010
- Decision Date
- February 10, 2011
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Renal Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Feb 15, 2013 | Substantially Equivalent |
| K121497 | VENOFER PUMP | Aug 17, 2012 | 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 |