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Lake Region Mfg., Inc.

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K092965 TRAILRUNNER GUIDEWIRESDQX2010-02-26 View
510(k) K082922 FREEWAY AND RAILRUNNER GUIDEWIRESDQX2008-12-09 View
510(k) K081708 TAXI ENDOSCOPIC GUIDEWIREOCY2008-08-26 View
510(k) K080144 MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26 View
510(k) K073655 PEGASUS STEERABLE (PTCA) GUIDEWIREDQX2008-01-28 View
510(k) K060454 TITAN GUIDEWIREDQX2006-03-24 View
510(k) K052347 TITAN STEERABLE (PTCA) GUIDEWIREDQX2006-02-17 View
510(k) K042338 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIREDQX2004-09-16 View
510(k) K041624 PTCA STEERABLE HYDROPHILIC GUIDEWIREDQX2004-07-16 View
510(k) K040825 LAKE REGION HYDROPHILIC GUIDEWIREDQX2004-05-17 View
510(k) K033758 HYDROPHILIC GUIDEWIREDQX2003-12-19 View
510(k) K022813 STEERABLE GUIDEWIREDQX2003-02-14 View
510(k) K011968 STREERABLE PTCA GUIDEWIREDQX2001-07-25 View
510(k) K011084 MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10 View
510(k) K003483 MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)DQX2000-12-06 View
510(k) K000011 MODIFIED HYDROPHILIC COATED GUIDEWIREDQX2000-03-01 View
510(k) K971322 CORE AND COIL ASSEMBLY GUIDEWIREDQX1998-07-22 View
510(k) K981326 LAKE REGION MANUFACTURING GUIDEWIRESDQX1998-07-10 View
510(k) K981667 HYDROPHILIC COATED GUIDEWIREKNY1998-06-05 View
510(k) K970376 PTCA GUIDEWIREDQX1997-06-06 View
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