Catheter Research, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1481-2015Class IIHSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonographApril 7, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K123258THE ADVANCE CATHETER FOR HSG AND SISJanuary 31, 2013
K120154INTRAUTERINE INSEMINATION (IUI) CATHETERMarch 21, 2012
K032835H/S CATHETER SETDecember 11, 2003
K020292UTERINE INJECTORApril 17, 2002
K973839DISPOSABLE ESOPHAGEAL STETHOSCOPEMarch 19, 1998
K974357UTERINE MANIPULATOR/INJECTORFebruary 2, 1998
K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGApril 14, 1995
K946044DISPOSABLE GAS SAMPLING LINESDecember 27, 1994