Medical Device Manufacturer · US , Chaska , MN

Lake Region Medical - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2008

Recent clearances: Enroute 0.014'' Transcarotid Guidewire, PTFE Guidewire, Pre-Formed Blue

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lake Region Medical Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Sep 19, 2014

Predicate III Guidewire

Gastroenterology & Urology · 23d

Cleared Apr 08, 2014

MANDREL GUIDEWIRE

Gastroenterology & Urology · 41d

Cleared Feb 26, 2013

OSTAVI HYDROPHILIC GUIDEWIRE

Gastroenterology & Urology · 57d

Cleared Mar 21, 2008

MANDREL GUIDEWIRES OR M-WIRE

Gastroenterology & Urology · 25d