Luther Medical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBNovember 30, 1998
K980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)March 24, 1998
K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFebruary 10, 1998
K940198L-CATH CONNECTOR ASSEMBLYDecember 15, 1994
K942103L-CATH CATHETER SYSTEM - PORT L-CATHJuly 26, 1994
K930473ONECATH L-CATH CATHETER SYSTEMApril 7, 1994
K925236L CATH(R) CATHETER SYSTEMMarch 22, 1994
K920755L-CATH PEEL AWAY SYSTEM CATHETERJune 7, 1993
K925979DUAL LUMEN L-CATH CATHETER SYSTEMMay 27, 1993
K924968L-CATH PEEL-AWAY CATHETER SYSTEMMay 21, 1993
K924562CATHETER INTRODUCERFebruary 25, 1993
K884806LUMED EXPANDO-CATH, ACTIVFebruary 8, 1989
K871546SAFESIDE(TM) LUMEDJune 17, 1987
K853348L-CATH EXPANDO CATHJanuary 9, 1986
K822217THERMOTHERAPYSeptember 24, 1982
K820102SUBCLAVIAN JUGULAR CATHETER SETJanuary 29, 1982
K801575L-CATH INTRAVENOUS PLACEMENT UNITAugust 20, 1980