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

42 devices

26-42 of 42

Cleared Mar 31, 1994

CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS

Cardiovascular · 155d

Cleared Sep 04, 1992

Gastroenterology & Urology · 176d

Cleared Dec 13, 1991

Cardiovascular · 88d

Cleared Nov 05, 1991

ISOLATE INFUSION CATHETR SYSTEM

Cardiovascular · 90d

Cleared Sep 23, 1991

PROFUSE INFUSION SYSTEM

Cardiovascular · 84d

Cleared Sep 11, 1991

OPEN ENDED GUIDEWIRE

Cardiovascular · 72d

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 May 15, 1986

DUTHOY STONE BASKET

Gastroenterology & Urology · 23d

Cleared May 06, 1986

FASICULATED NAIL

Orthopedic · 25d

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