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Lake Region Mfg., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K092965TRAILRUNNER GUIDEWIRESFebruary 26, 2010
K082922FREEWAY AND RAILRUNNER GUIDEWIRESDecember 9, 2008
K081708TAXI ENDOSCOPIC GUIDEWIREAugust 26, 2008
K080144MANDREL GUIDEWIRES OR M-WIRESFebruary 26, 2008
K073655PEGASUS STEERABLE (PTCA) GUIDEWIREJanuary 28, 2008
K060454TITAN GUIDEWIREMarch 24, 2006
K052347TITAN STEERABLE (PTCA) GUIDEWIREFebruary 17, 2006
K042338CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRESeptember 16, 2004
K041624PTCA STEERABLE HYDROPHILIC GUIDEWIREJuly 16, 2004
K040825LAKE REGION HYDROPHILIC GUIDEWIREMay 17, 2004
K033758HYDROPHILIC GUIDEWIREDecember 19, 2003
K022813STEERABLE GUIDEWIREFebruary 14, 2003
K011968STREERABLE PTCA GUIDEWIREJuly 25, 2001
K011084MANDREL GUIDEWIRE ASSEMBLYMay 10, 2001
K003483MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)December 6, 2000
K000011MODIFIED HYDROPHILIC COATED GUIDEWIREMarch 1, 2000
K971322CORE AND COIL ASSEMBLY GUIDEWIREJuly 22, 1998
K981326LAKE REGION MANUFACTURING GUIDEWIRESJuly 10, 1998
K981667HYDROPHILIC COATED GUIDEWIREJune 5, 1998
K970376PTCA GUIDEWIREJune 6, 1997