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FDA Product Code

FDA Product Code OMF — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.5970

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K093510 LUMENVU CATHETER GUIDANCE SYSTEM Sonosite,Inc. 2010-08-23 Traditional PDF ↗
K083121 NEO MAPCATH SENSOR STYLET Corpak Medsystems 2009-02-11 Traditional PDF ↗

Product code OMF · Class II · General Hospital. Data: openFDA.