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510(k) K083210

CORFLO ANTI IV ENTERAL FEEDING TUBE by Corpak Medsystems — Product Code FPD

K083210 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORFLO ANTI IV ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on December 29, 2008. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2008
Date Received
October 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Corpak Medsystems

  • K142012 — FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS (November 20, 2014)
  • K133599 — CORGRIP (March 26, 2014)
  • K131532 — ELECTROMAGNETIC TRANSMITTING STYLET (August 12, 2013)
  • K113351 — CORTRAK ENTERAL ACCESS DEVICE (January 10, 2012)
  • K100365 — FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV (May 20, 2010)
  • K091637 — CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (September 29, 2009)
  • K083776 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (March 5, 2009)
  • K083791 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S (March 4, 2009)
  • K083786 — CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AI (February 20, 2009)
  • K083121 — NEO MAPCATH SENSOR STYLET (February 11, 2009)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)

FDA data resources