FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRISMAFLEX M150 SET
K Number: K080519
·
Decision Jun 13, 2008
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
336
Applicant Total
13
Review Days
109
Basic Information
- Device Name
- PRISMAFLEX M150 SET
- K Number
- K080519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GAMBRO RENAL PRODUCTS, INC.
- Date Received
- February 25, 2008
- Decision Date
- June 13, 2008
- 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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FDA 510(k)
FDA Class 2
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Other Clearances by GAMBRO RENAL PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | Mar 26, 2014 | Substantially Equivalent |
| K131516 | PRISMAFLEX SYSTEM 7.10 | Jan 3, 2014 | Substantially Equivalent |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | May 2, 2013 | Substantially Equivalent |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Dec 14, 2012 | Substantially Equivalent |
| K110823 | PRISMAFLEX | Jun 17, 2011 | Substantially Equivalent |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | May 20, 2011 | Substantially Equivalent |
| K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 | Dec 21, 2010 | Substantially Equivalent |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Nov 3, 2010 | Substantially Equivalent |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Jul 29, 2010 | Substantially Equivalent |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Sep 7, 2007 | Substantially Equivalent |