FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K Number: K801731
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
315
Review Days
19
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
- C-DAK DUO-FLUX ARTIFICIAL KIDNEY
- K Number
- K801731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cordis Corp.
- Date Received
- July 25, 1980
- Decision Date
- August 13, 1980
- 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 Cordis Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM | Mar 12, 2014 | Unknown |
| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | May 4, 2012 | Substantially Equivalent |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Jul 9, 2010 | Substantially Equivalent |
| K082143 | MICRO GUIDE CATHETER XP | Aug 25, 2008 | Substantially Equivalent |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | Feb 6, 2008 | Unknown |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Apr 27, 2006 | Unknown |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | Apr 1, 2005 | Substantially Equivalent |
| K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Nov 8, 2004 | Unknown |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Dec 22, 2003 | Unknown |