Lake Region Medical

FDA Filings

This page includes the latest FDA filings for Lake Region Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Lake Region Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2126666
FEI Number2126666
NameLake Region Medical
Owner & OperatorLake Region Medical
Contact Address340 Lake Hazeltine Drive --
Chaska MN 55318 US
Official Correspondent
  • Karen - Anderson
  • x-952-6418509-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address340 Lake Hazeltine Dr
CHASKA, MN 55318 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number9681477
FEI Number3002807439
NameKaren Anderson
Owner & OperatorLake Region Medical
Contact Address340 Lake Hazeltine Drive --
Chaska MN 55318 US
Official Correspondent
  • Karen - Anderson
  • x-952-6418509-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address340 Lake Hazeltine Dr
CHASKA, MN 55318 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number2431982
FEI Number2431982
NameVenusa Ltd.
Owner & OperatorLake Region Medical
Contact Address100 FORDHAM ROAD BLDG C
Wilmington MA 01887 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address31 BUTTERFIELD TRAIL BLVD STE C
EL PASO, TX 79906 US



Registration Number9680001
FEI Number3002808445
NameVenusa de Mexico S. de R.L de C.V
Owner & OperatorLake Region Medical
Contact Address100 FORDHAM ROAD BLDG C
Wilmington MA 01887 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCALLE HERTZ 1525 Parque Industrial Antonio J. Bermudez
CIUDAD JUAREZ Chihuahua, 32470 MX
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



Registration Number3004063494
FEI Number3004063494
NameLake Region Medical
Owner & OperatorLake Region Medical
Contact Address100 FORDHAM ROAD BLDG C
Wilmington MA 01887 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address13024 NORTH MAIN ST.
TRENTON, GA 30752 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
NaviPro™ 2023-12-06
Lake Region Medical
Circulo 15R2011-06-0012022-10-21
Lake Region Medical
Circulo 15R2011-06-0022022-10-21
Lake Region Medical
Pre-Formed Blue2022-10-07
Lake Region Medical
Safari2 Extra Support SCMBW-019V2022-04-01
Lake Region Medical
Safari2 Extra Support SCMBW-022V2022-04-01
Lake Region Medical
Safari2 Extra Support SCMBW-021V2022-04-01
Lake Region Medical
Safari2 Extra Support SCMBW-020V2022-04-01
Lake Region Medical
Safari2 Extra Support SCMBW-018V2022-04-01
Lake Region Medical
Safari2 Extra Support SCMBW-017V2022-04-01
Lake Region Medical
Jetstream™ Jetwire 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
ZIPwire™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
Thruway™ 2021-12-22
Lake Region Medical
ZipWire VNTBR-0422020-07-08
Lake Region Medical
ZipWire VNTBR-0412020-07-08
Lake Region Medical
ZipWire VNTBR-0402020-07-08
Lake Region Medical
ZipWire VNTBR-0392020-07-08
Lake Region Medical
ZipWire VNTBR-0382020-07-08
Lake Region Medical
ZipWire VNTBR-0362020-07-08
Lake Region Medical
ZipWire VNTBR-0352020-07-08
Lake Region Medical
ZipWire VNTBR-0342020-07-08
Lake Region Medical
ZipWire VNTBR-0322020-07-08
Lake Region Medical
ZipWire VNTBR-0312020-07-08
Lake Region Medical
ZipWire VNTBR-0302020-07-08
Lake Region Medical
ZipWire VNTBR-0292020-07-08
Lake Region Medical
ZipWire VNTBR-0372020-07-08
Lake Region Medical
ZipWire VNTBR-0332020-07-08
Lake Region Medical
ZipWire VNTBR-0282020-07-08
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien Electrosurgical2020-04-02
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Wire, Guide, Catheter2020-01-02
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Wire, Guide, Catheter NaviPro2019-12-17
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Wire, Guide, Catheter ZIPwire2019-12-17
Lake Region Medical
Callisyn 2.7Fr Microcatheter2018-08-20
LAKE REGION MEDICAL
ENROUTE 0.014 Guidewire2016-10-18
Lake Region Medical
Merit Medical EmboCath Plus2016-05-20
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Synergetics2016-03-08
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Intact Medical Corporation2016-02-16
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
DePuy Mitek2015-10-20
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Depuy Mitek2015-10-20
Lake Region Medical
Pre-Formed Guidewire2015-06-11
Lake Region Medical
Infiniti Vision System (with I/A Tips (HQR being part of the System)2015-03-02
Lake Region Medical
Infiniti Vision System (with I/A Tips (HQR being part of the System)2015-03-02
Lake Region Medical
Infiniti Vision System (with I/A Tips (HQR being part of the System)2015-03-02
LAKE REGION MEDICAL
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE2014-12-17
LAKE REGION MEDICAL
PREDICATE III GUIDEWIRE2014-11-25
Lake Region Medical
Predicate III2014-10-30
Karen Anderson [Lake Region Medical]
Predicate III2014-10-30
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
St. Jude Medical2014-10-29
Lake Region Medical
Predicate III Guidewire2014-09-19
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEUROTHERM2014-06-03
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEUROTHERM2014-06-03
LAKE REGION MEDICAL
MANDREL GUIDEWIRE2014-04-08
LAKE REGION MEDICAL
HYDROPHILIC COATED GUIDEWIRE2014-04-07
LAKE REGION MEDICAL
MANDREL GUIDEWIRE2014-03-27
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Biosense Webster Inc2013-03-19
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Biosense Webster Inc2013-03-19
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Biosense Webster Inc2013-03-19
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Biosense Webster Inc2013-03-19
LAKE REGION MEDICAL
OSTAVI HYDROPHILIC GUIDEWIRE2013-02-26
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien electrosurgical2013-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien2013-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien electrosurgical2013-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien electrosurgical2013-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Covidien electrosurgical2013-02-21
Lake Region Medical
Surefire High Flow Angiographic Catheter2013-01-17
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
BOSTON SCIENTIFIC2013-01-11
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH & NEPHEW INC., ENDOSCOPY DIVISION2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH AND NEPHEW ENDOSCOPY2012-02-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH AND NEPHEW ENDOSCOPY2012-02-21
LAKE REGION MEDICAL
HI TORQUE CONNECT GUIDEWIRE2011-11-03
LAKE REGION MEDICAL
ANCHORWIRE GUIDEWIRE2011-08-02
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
KCI USA, INC. (KINETIC CONCEPTS, INC.)2011-07-20
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
FUTURE MEDICAL SYSTEMS, INC2011-04-05
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
KCI USA, INC. (KINETIC CONCEPTS, INC.)2011-03-17
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
BOSTON SCIENTIFIC CORP2011-01-27
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
KCI USA, INC. (KINETIC CONCEPTS, INC.)2011-01-20
Lake Region Medical
K9351982009-02-05
Karen Anderson [Lake Region Medical]
K9351982009-02-05
Lake Region Medical
GLADIATOR GUIDEWIRE2009-02-02
Lake Region Medical
K0801442008-11-03
Karen Anderson [Lake Region Medical]
K0801442008-11-03
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
VENUSA LTD.2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEO HANDLE2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
EN BLOC Biopsy System2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
BLES HANDLE2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEO HANDLE2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
EN BLOC Biopsy System2008-08-01
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
BLES HANDLE2008-08-01
LAKE REGION MEDICAL
MANDREL GUIDEWIRES OR M-WIRE2008-03-21
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
OnePort Surgical Trocar System2008-01-08
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Prolieve Thermodilatation System2007-12-27
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
Dendreon Corporation2007-12-27
Karen Anderson [Lake Region Medical]
K9703762007-12-05
Lake Region Medical
K9351702007-12-05
Karen Anderson [Lake Region Medical]
K9351702007-12-05
Lake Region Medical
K9141382007-12-05
Lake Region Medical
Torque Device2007-12-05
Karen Anderson [Lake Region Medical]
Torque Device2007-12-05
Lake Region Medical
K8508292007-12-05
Karen Anderson [Lake Region Medical]
K8508292007-12-05
Lake Region Medical
K7709772007-12-05
Karen Anderson [Lake Region Medical]
K7709772007-12-05
Lake Region Medical
K0119682007-12-05
Lake Region Medical
K0000112007-12-05
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH2006-10-26
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEPHEW RF DENERVATION PROBES2006-10-26
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH2006-10-26
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEPHEW RF DENERVATION PROBES2006-10-26
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
ELECTROSURGICAL ELECTROBLADE2006-09-28
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
SMITH2006-09-28
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
NEPHEW CDS SYSTEM2006-09-28
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
STONE CONE(TM) NITINOL U2005-10-25
Venusa de Mexico S. de R.L de C.V [Lake Region Medical]
ORATEC SPINECATH I2005-05-18

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092668033Genova,Italy -> New York/Newark Area, Newark, New JerseyPLASTIC COMPONENTS FOR MEDICAL USE HTS 90189085HTS1 PCS
2020090226144Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020090226144Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
202008256383Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
202008256383Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020081226532Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020081226532Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020081128193Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020081128193Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE28 PKG
2020072956800Hong Kong,Hong Kong -> Long Beach, CaliforniaMEDICAL CABLETARIFF CODE 8544421900AS PER PACKING LIST CM202006467HS CODE 8544421900THIS SHIPMENT DOES NOT CONTAIN WOOD PACKAGING MATERIALS37 CTN
2020071758317Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES FOR SURGICAL USE18 PKG
2020071758317Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICES FOR SURGICAL USE18 PKG
202007144661Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE34 PKG
202007144661Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE34 PKG
202007144661Anvers,Belgium -> Los Angeles, CaliforniaMEDICAL DEVICES FOR SURGICAL USE34 PKG

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