FDA.report

Lake Region Medical

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21266662126666Lake Region Medical1Y2026-01-01340 Lake Hazeltine Dr CHASKA MN US 55318
30040634943004063494Lake Region Medical1N2026-01-0113024 NORTH MAIN ST. TRENTON GA US 30752

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
356341514980828K991486ULTRA-CBXDWZ1999-11-05
356341603285729K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
356341735713410K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
356341384561067K914138ONTRACDQX1991-12-13
356341541898588K905639TORQUE HANDLE DEVICE FOR GUIDEWIREDQX1991-02-20
356341778026819K905581SILICONE COATED GUIDEWIRESDQX1991-02-19
356341996011574K850829WIRE, GUIDE, CATHETERDQY1985-06-26
356341488620868K850828WIRE, GUIDE - MODIFICATIONDQX1985-06-26
356341457663531K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
356341486288333K802473BENZALKONIUM-HEPARIN COATED GUIDEWIRESDQX1980-11-12
356341892588815K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
356341791938958K760944ANGIOGRAPHIC GUIDEWIREDQX1976-12-10
356341071905195K242824PTFE GuidewireDQX2024-12-06
356341737761631K221575Pre-Formed BlueDQX2022-10-07
356341726500955K211741Pre-Formed Extra Support GuidewireDQX2021-11-22
203791593338773K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmKRA2017-01-27
356341054488267K151244Pre-Formed GuidewireDQX2015-06-11
356341868442439K142397Predicate III GuidewireOCY2014-09-19
356341002566477K142393PREDICATE III GUIDEWIREDQX2014-11-25
356341692035125K140485MANDREL GUIDEWIREDQX2014-03-27
356341921952984K140482MANDREL GUIDEWIREOCY2014-04-08
356341546682188K133155HYDROPHILIC COATED GUIDEWIREDQX2014-04-07
356341239622095K130798PRE-FORMED GUIDEWIRESDQX2013-08-23
356341306464312K124052OSTAVI HYDROPHILIC GUIDEWIREOCY2013-02-26
356341168615286K122795STINGRAY GUIDEWIRESDQX2012-11-08
203791464028996K122506SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESSDQX2012-09-17
356341298574472K111288ANCHORWIRE GUIDEWIREDQX2011-08-02
356341605598799K102725CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND MDQY2011-05-10
356341863954190K092965TRAILRUNNER GUIDEWIRESDQX2010-02-26
356341863574013K082922FREEWAY AND RAILRUNNER GUIDEWIRESDQX2008-12-09
356341457145907K081708TAXI ENDOSCOPIC GUIDEWIREOCY2008-08-26
203791928950643K062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135DQO2006-08-09
356341300516514K060454TITAN GUIDEWIREDQX2006-03-24
356341923237474K052347TITAN STEERABLE (PTCA) GUIDEWIREDQX2006-02-17
356341903293863K042338CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIREDQX2004-09-16
356341438747885K041624PTCA STEERABLE HYDROPHILIC GUIDEWIREDQX2004-07-16
356341242600269K033758HYDROPHILIC GUIDEWIREDQX2003-12-19
356341557765775K022813STEERABLE GUIDEWIREDQX2003-02-14
356342036289498K011968STREERABLE PTCA GUIDEWIREDQX2001-07-25
356341001611463K011084MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10
356341096407964K000011MODIFIED HYDROPHILIC COATED GUIDEWIREDQX2000-03-01
356341055320526
356341061020423
356341061051133
356341074219878
356341085177840
356341101050807
356341107700239
356341166214762
356341191336809
356341195743666
356341206630592
356341213164899
356341240189153
356341251591186
356341256431230
356341268925967
356341282078556
356341292479941
356341326241671
356341330854645
356341360684787
356341381961414
356341499628048
356341584124275
203791591809810
356341599099961
356341611394813
356341636081244
356341683943636
356341706279282
356341833399151
356341889030766
356341908864408
356341974710576
356342002731230
203792063495572

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQX312024-12-06
OCY42014-09-19
DQY22011-05-10
KRA12017-01-27
DQO12006-08-09
DWZ11999-11-05
KNT11994-09-28

PMN

GUDID

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