FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDIA S4 -TREPONEMA PALLIDUM
K Number: K850329
·
Decision Jul 2, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
34
Applicant Total
315
Review Days
155
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Basic Information
- Device Name
- CORDIA S4 -TREPONEMA PALLIDUM
- K Number
- K850329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Cordis Corp.
- Date Received
- January 28, 1985
- Decision Date
- July 2, 1985
- Product Code
- LIP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | FDA class 2 | Microbiology |
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|---|---|---|---|
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| 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 |