FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCOR HPH 700 HEMOCONCENTRATOR
K Number: K983085
·
Decision Nov 13, 1998
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
33
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMOCOR HPH 700 HEMOCONCENTRATOR
- K Number
- K983085
- 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
- September 3, 1998
- Decision Date
- November 13, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDI), ordered by most recent decision date.
NxStage System One with NxView
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELISIO-H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
multiFlux 130 (F00013123); multiFlux 160 (F00013124)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FX CorAL 40; FX CorAL 50
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Purema H Hemoconcentrator - Pediatric
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | Apr 4, 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 |