FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENAFLO II HF 2000 HEMOFILTER
K Number: K000028
·
Decision Apr 4, 2000
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
33
Review Days
90
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Basic Information
- Device Name
- RENAFLO II HF 2000 HEMOFILTER
- K Number
- K000028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minntech Corp.
- Date Received
- January 5, 2000
- Decision Date
- April 4, 2000
- 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 Minntech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120306 | RAPICIDE OPA-28 | Sep 27, 2012 | Substantially Equivalent |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Apr 5, 2010 | Substantially Equivalent |
| K071298 | HF JUNIOR HEMOFILTER | Aug 8, 2007 | Substantially Equivalent |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | Jan 31, 2006 | Substantially Equivalent |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Apr 27, 2004 | Substantially Equivalent |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Feb 1, 2002 | Substantially Equivalent |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | Jun 8, 2000 | Substantially Equivalent |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Aug 30, 1999 | Substantially Equivalent |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | Mar 8, 1999 | Substantially Equivalent |
| K983085 | HEMOCOR HPH 700 HEMOCONCENTRATOR | Nov 13, 1998 | Substantially Equivalent |