Lake Region Mfg Inc

FDA Filings

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

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

FDA Registration(s)
Registration Number3006010712
FEI Number3006010712
NameBRIVANT, LTD.
Owner & OperatorLAKE REGION MFG., INC
Contact AddressLAKE REGION MFG., INC 340 Lake Hazeltine Drive
Chaska MN 55318 US
Official Correspondent
  • KAREN - ANDERSON
  • x-952-4485111-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPARKMORE WEST BUSINESS PARK
GALWAY Galway, -- IE
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
BRIVANT, LTD. [LAKE REGION MFG., INC]
Hi Torque Vektor Guidewires2019-05-01
LAKE REGION MFG., INC.
TRAILRUNNER GUIDEWIRES2010-02-26
LAKE REGION MFG., INC.
FREEWAY AND RAILRUNNER GUIDEWIRES2008-12-09
LAKE REGION MFG., INC.
TAXI ENDOSCOPIC GUIDEWIRE2008-08-26
LAKE REGION MFG., INC.
MANDREL GUIDEWIRES OR M-WIRES2008-02-26
LAKE REGION MFG., INC.
PEGASUS STEERABLE (PTCA) GUIDEWIRE2008-01-28
LAKE REGION MFG., INC.
TITAN GUIDEWIRE2006-03-24
LAKE REGION MFG., INC.
TITAN STEERABLE (PTCA) GUIDEWIRE2006-02-17
LAKE REGION MFG., INC.
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE2004-09-16
LAKE REGION MFG., INC.
PTCA STEERABLE HYDROPHILIC GUIDEWIRE2004-07-16
LAKE REGION MFG., INC.
LAKE REGION HYDROPHILIC GUIDEWIRE2004-05-17
LAKE REGION MFG., INC.
HYDROPHILIC GUIDEWIRE2003-12-19
LAKE REGION MFG., INC.
STREERABLE PTCA GUIDEWIRE2001-07-25
LAKE REGION MFG., INC.
MANDREL GUIDEWIRE ASSEMBLY2001-05-10
LAKE REGION MFG., INC.
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)2000-12-06
LAKE REGION MFG., INC.
MODIFIED HYDROPHILIC COATED GUIDEWIRE2000-03-01
LAKE REGION MFG., INC.
CORE AND COIL ASSEMBLY GUIDEWIRE1998-07-22
LAKE REGION MFG., INC.
LAKE REGION MANUFACTURING GUIDEWIRES1998-07-10
LAKE REGION MFG., INC.
HYDROPHILIC COATED GUIDEWIRE1998-06-05
LAKE REGION MFG., INC.
PTCA GUIDEWIRE1997-06-06
LAKE REGION MFG., INC.
CORE AND COIL ASSEMBLY GUIDEWIRE1997-03-25
LAKE REGION MFG., INC.
LRM1996-05-21
LAKE REGION MFG., INC.
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.1996-04-05
LAKE REGION MFG., INC.
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS1994-09-28
LAKE REGION MFG., INC.
ONTRAC STEERABLE GUIDEWIRE1994-05-12
LAKE REGION MFG., INC.
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS1994-03-31
LAKE REGION MFG., INC.
GUIDEWIRE1992-09-04
LAKE REGION MFG., INC.
ONTRAC1991-12-13
LAKE REGION MFG., INC.
ISOLATE INFUSION CATHETR SYSTEM1991-11-05
LAKE REGION MFG., INC.
PROFUSE INFUSION SYSTEM1991-09-23
LAKE REGION MFG., INC.
OPEN ENDED GUIDEWIRE1991-09-11
LAKE REGION MFG., INC.
TORQUE HANDLE DEVICE FOR GUIDEWIRE1991-02-20
LAKE REGION MFG., INC.
SILICONE COATED GUIDEWIRES1991-02-19
LAKE REGION MFG., INC.
INSITE STEERABLE GUIDEWIRE1990-06-11
LAKE REGION MFG., INC.
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)1987-09-15
LAKE REGION MFG., INC.
AMPLATZ MOVEABLE CORE GUIDEWIRE1987-02-19
LAKE REGION MFG., INC.
DUTHOY STONE BASKET1986-05-15
LAKE REGION MFG., INC.
FASICULATED NAIL1986-05-06
LAKE REGION MFG., INC.
WIRE, GUIDE, CATHETER1985-06-26
LAKE REGION MFG., INC.
WIRE, GUIDE - MODIFICATION1985-06-26
LAKE REGION MFG., INC.
GUIDE, WIRE, ANGIOGRAPHIC1985-06-26
LAKE REGION MFG., INC.
CARDIOVASCULAR SPRING GUIDES1977-06-14

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