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

FDA 510(k) Regulatory Record - Lake Region Mfg., Inc. Cardiovascular ✕

34 devices

1-12 of 34

Cleared Feb 26, 2010

TRAILRUNNER GUIDEWIRES

Cardiovascular · 154d

Cleared Dec 09, 2008

FREEWAY AND RAILRUNNER GUIDEWIRES

Cardiovascular · 69d

Cleared Feb 26, 2008

MANDREL GUIDEWIRES OR M-WIRES

Cardiovascular · 35d

Cleared Jan 28, 2008

PEGASUS STEERABLE (PTCA) GUIDEWIRE

Cardiovascular · 33d

Cleared Mar 24, 2006

TITAN GUIDEWIRE

Cardiovascular · 30d

Cleared Feb 17, 2006

TITAN STEERABLE (PTCA) GUIDEWIRE

Cardiovascular · 172d

Cleared Sep 16, 2004

CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE

Cardiovascular · 17d

Cleared Jul 16, 2004

PTCA STEERABLE HYDROPHILIC GUIDEWIRE

Cardiovascular · 30d

Cleared May 17, 2004

LAKE REGION HYDROPHILIC GUIDEWIRE

Cardiovascular · 48d

Cleared Dec 19, 2003

HYDROPHILIC GUIDEWIRE

Cardiovascular · 17d

Cleared Feb 14, 2003

STEERABLE GUIDEWIRE

Cardiovascular · 172d

Cleared Jul 25, 2001

STREERABLE PTCA GUIDEWIRE

Cardiovascular · 30d