Home / 510(k) Clearances / K083121

510(k) K083121

NEO MAPCATH SENSOR STYLET by Corpak Medsystems — Product Code OMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2009
Date Received
October 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

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

Other clearances for product code OMF

  • K093510 — LUMENVU CATHETER GUIDANCE SYSTEM (August 23, 2010)