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510(k) K142012

FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS by Corpak Medsystems — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2014
Date Received
July 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

Other clearances by Corpak Medsystems

  • 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)
  • K083210 — CORFLO ANTI IV ENTERAL FEEDING TUBE (December 29, 2008)

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  • K233034 — Mobility+ Enteral Feeding System OTC (April 12, 2024)
  • K230326 — ENFit to ENFit Extension Sets (November 2, 2023)
  • K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT (October 6, 2023)
  • K222773 — Feeding Tube (August 17, 2023)
  • K223683 — EnteraLoc Flow (July 10, 2023)
  • K222678 — Mobility+ Enteral Feeding System (October 27, 2022)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)