FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI HEMOCONCENTRATOR PREFERENCE PACK
K Number: K970739
·
Decision Jul 8, 1997
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
35
Review Days
130
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
- RMI HEMOCONCENTRATOR PREFERENCE PACK
- K Number
- K970739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Research Medical, Inc.
- Date Received
- February 28, 1997
- Decision Date
- July 8, 1997
- 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 Research Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Feb 19, 1997 | Substantially Equivalent |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | Aug 13, 1996 | Substantially Equivalent |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Mar 26, 1996 | Substantially Equivalent |
| K951344 | RMI HEMOCONCENTRATOR | Aug 15, 1995 | Substantially Equivalent |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Jan 29, 1993 | Substantially Equivalent |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Dec 8, 1992 | Substantially Equivalent |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent |
| K901231 | RMI CARDIOPLEGIA DELIVERY KITS | Jun 8, 1990 | Substantially Equivalent |