FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORFLO ANTI IV ENTERAL FEEDING TUBE
K Number: K083210
·
Decision Dec 29, 2008
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
15
Review Days
59
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Basic Information
- Device Name
- CORFLO ANTI IV ENTERAL FEEDING TUBE
- K Number
- K083210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Corpak Medsystems
- Date Received
- October 31, 2008
- Decision Date
- December 29, 2008
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Corpak Medsystems
| K Number | Device Name | ||
|---|---|---|---|
| K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | Nov 20, 2014 | Substantially Equivalent |
| K133599 | CORGRIP | Mar 26, 2014 | Substantially Equivalent |
| K131532 | ELECTROMAGNETIC TRANSMITTING STYLET | Aug 12, 2013 | Substantially Equivalent |
| K113351 | CORTRAK ENTERAL ACCESS DEVICE | Jan 10, 2012 | Substantially Equivalent |
| K100365 | FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV | May 20, 2010 | Substantially Equivalent |
| K091637 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | Sep 29, 2009 | Substantially Equivalent |
| K083776 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S | Mar 5, 2009 | Substantially Equivalent |
| K083791 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S | Mar 4, 2009 | Substantially Equivalent |
| K083786 | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB | Feb 20, 2009 | Substantially Equivalent |
| K083121 | NEO MAPCATH SENSOR STYLET | Feb 11, 2009 | Substantially Equivalent |