Distronic Sterile Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K955709WINGED & SUBCUTANEOUS INFUSION SETSFebruary 21, 1996
K955732VENTED SOLUTION SETFebruary 21, 1996
K954983EXTENSION SET WITH CHECK VALVEJanuary 23, 1996
K954984MINIBORE STOPCOCK SETJanuary 23, 1996
K952664SOLUTION ADMINISTRATION SETAugust 7, 1995
K950597CORE-RESISTANT HUBER INFUSION SET WITH Y-SITEJuly 26, 1995
K95266360 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, July 14, 1995
K945184INTRAVASCULAR ADMINISTRATION SETFebruary 8, 1995