Medical Device Manufacturer · US , Mchenry , IL

Lake Region Mfg., Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1977

42

Total

42

Cleared

0

Denied

34 devices

26-34 of 34

Cleared Feb 20, 1991

TORQUE HANDLE DEVICE FOR GUIDEWIRE

Cardiovascular · 65d

Cleared Feb 19, 1991

SILICONE COATED GUIDEWIRES

Cardiovascular · 69d

Cleared Jun 11, 1990

INSITE STEERABLE GUIDEWIRE

Cardiovascular · 89d

Cleared Sep 15, 1987

LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)

Cardiovascular · 127d

Cleared Feb 19, 1987

AMPLATZ MOVEABLE CORE GUIDEWIRE

Cardiovascular · 122d

Cleared Jun 26, 1985

GUIDE, WIRE, ANGIOGRAPHIC

Cardiovascular · 121d

Cleared Jun 26, 1985

WIRE, GUIDE - MODIFICATION

Cardiovascular · 121d

Cleared Jun 26, 1985

WIRE, GUIDE, CATHETER

Cardiovascular · 121d

Cleared Jun 14, 1977

CARDIOVASCULAR SPRING GUIDES

Cardiovascular · 14d