Diatek, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K020430DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)May 9, 2002
K010399DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC32August 14, 2001
K895703DIATEK MODEL 700 THERMOMETERDecember 7, 1989
K872178MODIFICATION TO ARKIVE(TM)January 27, 1988
K862085ARKIVE (TM)January 12, 1987
K841827ENTEROPORT NUTRITION PUMPJuly 27, 1984
K841859SECURA SETJuly 3, 1984
K833568DIATEK 600 THERMOMETER SYSTEMJanuary 10, 1984
K830565SECURA SET SECONDARY ADMIN. SETMarch 9, 1983
K830377SECURA SET PRIMARY ADMIN. SETMarch 1, 1983
K830355SECURA IV VOLUMETRIC INFUSION PUMPMarch 1, 1983
K830448SECURA SET VOLUME LIMITING SETFebruary 25, 1983
K813468ACC-U-THERM TEMPERATURE MONITORJanuary 7, 1982
K810575MARTIN TRACH-SECUREMarch 17, 1981
K790416DIATEK 500April 10, 1979