FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIDNEY, ARTIFICIAL, C-DAK 1.5
K Number: K781238
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
30
Applicant Total
315
Review Days
42
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Basic Information
- Device Name
- KIDNEY, ARTIFICIAL, C-DAK 1.5
- K Number
- K781238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Cordis Corp.
- Date Received
- July 20, 1978
- Decision Date
- August 31, 1978
- Product Code
- DJC
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Apr 27, 2006 | Unknown |
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| 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 |