Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681477

FEI Number

3002807439

Entity Name

LAKE REGION MEDICAL LIMITED

City/State/Country

NEW ROSS Wexford, IE

Establishment Address

BUTLERSLAND, NEW ROSS Wexford --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lake Region Medical (Owner Number: 2126666)

Owner / Operator Contact Address

340 Lake Hazeltine Drive, --, Chaska, MN 55318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242824

PMA Number

N/A

All Registered Proprietary Names

Precision Lead Blank K970376 K935198 Steerant Super Stiff Guidewire K080144 Predicate III K850829

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-08-09
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2021-12-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-05-01
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2016-08-30
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2013-04-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-05
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2009-02-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-12-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-05
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2013-01-29
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-29
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-04-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-29
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-01-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-29
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2013-01-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-03-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-11-03
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-10-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-24
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-06-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-01-24
MAJ	Catheter, Percutaneous, Intraspinal, Short Term	Anesthesiology	Class 2	868.5120	2013-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-06-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

Charlene Grilletto Business: Lake Region Medical Email: charlene.grilletto@integer.net Phone: (267) 4508860

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
2126666	Lake Region Medical	CHASKA, MN, US
3006010712	BRIVANT, LTD.	GALWAY, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681477. Last updated year: 2026. Please use registration number 9681477 when referencing this establishment in official correspondence.