FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K Number: K982414
·
Decision Mar 26, 1999
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
13
Review Days
256
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Basic Information
- Device Name
- GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
- K Number
- K982414
- 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 Healthcare
- Date Received
- July 13, 1998
- Decision Date
- March 26, 1999
- 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 Gambro Healthcare
| K Number | Device Name | ||
|---|---|---|---|
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | Oct 26, 2000 | Substantially Equivalent |
| K990039 | GAMBRO DQM 200 | Jan 27, 2000 | Substantially Equivalent |
| K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS | Apr 21, 1999 | Substantially Equivalent |
| K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) | Feb 24, 1999 | Substantially Equivalent |
| K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET | Nov 4, 1998 | Substantially Equivalent |
| K982818 | HOSPAL TIPSTOP | Oct 21, 1998 | Substantially Equivalent |
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | Sep 23, 1998 | Substantially Equivalent |
| K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | Aug 11, 1998 | Substantially Equivalent |
| K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | May 18, 1998 | Substantially Equivalent |
| K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET | Sep 26, 1997 | Substantially Equivalent |