Lake Region Medical

FDA Device Registration & Listing · CHASKA, MN, US · Registration 2126666

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2126666
FEI Number
2126666
Entity Name
Lake Region Medical
City/State/Country
CHASKA, MN, US
Establishment Address
340 Lake Hazeltine Dr, CHASKA, MN 55318, US
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Lake Region Medical (Owner Number: 2126666)
Owner / Operator Contact Address
340 Lake Hazeltine Drive, --, Chaska, MN 55318, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K042338
PMA Number
N/A

All Registered Proprietary Names

K935198 K850829 Predicate III K914138 K000011 K770977 K935170 GLADIATOR GUIDEWIRE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2009-02-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-30
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2008-11-03
LJE Catheter, Nephrostomy Unknown Class U N/A 2008-11-03
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2008-11-03
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2008-11-03
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2008-11-03
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-11-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-11-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
EYA Stylet, Ureteral Gastroenterology, Urology Class 1 876.5130 2013-04-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-11-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2014-06-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-07-14
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2013-01-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-03-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-03-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-06-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-24
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-10-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-15
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2015-03-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2021-11-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-08-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-30
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2013-01-23
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2013-01-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-11-03
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2013-01-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2023-11-21
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2016-07-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-05-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-10-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-11-07
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2013-01-30
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2013-03-06
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2014-03-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-11-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-11-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-11-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-02-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-04-30
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-06-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-09-05
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2015-08-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-11-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-05

Official Correspondent

Deko Hussein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lake Region Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004063494 Lake Region Medical TRENTON, GA, US
9680001 Venusa de Mexico S. de R.L de C.V CIUDAD JUAREZ Chihuahua, MX
9681477 LAKE REGION MEDICAL LIMITED NEW ROSS Wexford, IE
3006010712 BRIVANT, LTD. GALWAY, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0037-2023 Hobbs Medical, Inc. 2
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023 Hobbs Medical, Inc. 2
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023 Hobbs Medical, Inc. 2
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023 Hobbs Medical, Inc. 2
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2126666. Last updated year: 2026. Please use registration number 2126666 when referencing this establishment in official correspondence.
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