FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K Number: K833078
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
315
Review Days
140
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Basic Information
- Device Name
- HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
- K Number
- K833078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cordis Corp.
- Date Received
- September 9, 1983
- Decision Date
- January 27, 1984
- Product Code
- DTZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Cordis Corp.
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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 |