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Data / Medical devices / United States / Lake Region Medical

Lake Region Medical: FDA-registered device maker in Chaska, MN, United States, 31 510(k) clearances

Lake Region Medical is registered with the FDA (registration 2126666) in Chaska, MN, United States. It lists 27 device types. The FDA files 31 510(k) clearances under its listings, the newest dated December 6, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Lake Region Medical
FDA registration number
2126666
Address
340 Lake Hazeltine Dr, Chaska, MN, United States, 55318
Owner or operator
Lake Region Medical (2126666)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
December 5, 2007
Registered through
2026
Brand names listed
Infiniti Vision System (with I/A Tips (HQR being part of the System), K000011, K011968, K080144, K770977, K850829, K914138, K935170 and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
Accessories, Catheter, G-UKNY2Specification developeraccessdata.fda.gov
Apparatus, Cautery, Radiofrequency, Ac-PoweredHQR2Contract manufactureraccessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA2Specification developeraccessdata.fda.gov
Catheter For Crossing Total OcclusionsPDU2Contract manufactureraccessdata.fda.gov
Catheter, Coronary, AtherectomyMCX3Contract manufactureraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Contract manufactureraccessdata.fda.gov
Catheter, NephrostomyLJEUSpecification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Contract manufacturer, Specification developeraccessdata.fda.gov
Catheter, SeptostomyDXF2Contract manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Contract manufactureraccessdata.fda.gov
Device, Biopsy, EndomyocardialDWZ2Manufactureraccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Contract manufactureraccessdata.fda.gov
Dilator, EsophagealKNQ2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufacturer, Specification developeraccessdata.fda.gov
Intracranial Neurovascular StentNJEfContract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Stent, UreteralFAD2Specification developeraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Specification developeraccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Specification developeraccessdata.fda.gov
Stylet, UreteralEYA1Manufactureraccessdata.fda.gov
Temporary Carotid Catheter For Embolic CaptureNTE2Contract manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Specification developeraccessdata.fda.gov
Unit, PhacofragmentationHQC2Contract manufactureraccessdata.fda.gov
Vitrectomy, Instrument CutterMLZ2Contract manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 6, 2024K242824PTFE GuidewireDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
October 7, 2022K221575Pre-Formed BlueDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
June 11, 2015K151244Pre-Formed GuidewireDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
November 25, 2014K142393PREDICATE III GUIDEWIREDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
September 19, 2014K142397Predicate III GuidewireOCYSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
April 8, 2014K140482MANDREL GUIDEWIREOCYSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
March 27, 2014K140485MANDREL GUIDEWIREDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
February 26, 2013K124052OSTAVI HYDROPHILIC GUIDEWIREOCYSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
August 2, 2011K111288ANCHORWIRE GUIDEWIREDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
August 26, 2008K081708TAXI ENDOSCOPIC GUIDEWIREOCYSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
March 21, 2008K080508MANDREL GUIDEWIRES OR M-WIREOCYSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
February 26, 2008K080144MANDREL GUIDEWIRES OR M-WIRESDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
September 16, 2004K042338CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
July 16, 2004K041624PTCA STEERABLE HYDROPHILIC GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
December 19, 2003K033758HYDROPHILIC GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
February 14, 2003K022813STEERABLE GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
July 25, 2001K011968STREERABLE PTCA GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
May 10, 2001K011084MANDREL GUIDEWIRE ASSEMBLYDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
March 1, 2000K000011MODIFIED HYDROPHILIC COATED GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
November 5, 1999K991486ULTRA-CBXDWZSubstantially EquivalentMedcanica, Inc.accessdata.fda.gov
June 6, 1997K970376PTCA GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
September 28, 1994K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNTSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
March 31, 1994K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
December 13, 1991K914138ONTRACDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
February 20, 1991K905639TORQUE HANDLE DEVICE FOR GUIDEWIREDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
February 19, 1991K905581SILICONE COATED GUIDEWIRESDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
June 26, 1985K850829WIRE, GUIDE, CATHETERDQYSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
June 26, 1985K850828WIRE, GUIDE - MODIFICATIONDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
June 26, 1985K850827GUIDE, WIRE, ANGIOGRAPHICDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
June 14, 1977K770977CARDIOVASCULAR SPRING GUIDESDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov
December 10, 1976K760944ANGIOGRAPHIC GUIDEWIREDQXSubstantially EquivalentMedrad, Inc.accessdata.fda.gov

Compare with other makers

Updated December 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.