Medical Device Manufacturer · US , Chaska , MN

Lake Region Medical - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2008

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lake Region Medical Cardiovascular ✕

12 devices

1-12 of 12

Cleared Mar 19, 2026

Enroute 0.014'' Transcarotid Guidewire

Cardiovascular · 114d

Cleared Dec 06, 2024

Cardiovascular · 79d

Cleared Oct 07, 2022

Pre-Formed Blue

Cardiovascular · 128d

Cleared Nov 22, 2021

Pre-Formed Extra Support Guidewire

Cardiovascular · 168d

Cleared Oct 18, 2016

ENROUTE 0.014 Guidewire

Cardiovascular · 225d

Cleared Jun 11, 2015

Pre-Formed Guidewire

Cardiovascular · 31d

Cleared Dec 17, 2014

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE...

Cardiovascular · 288d

Cleared Nov 25, 2014

PREDICATE III GUIDEWIRE

Cardiovascular · 90d

Cleared Apr 07, 2014

HYDROPHILIC COATED GUIDEWIRE

Cardiovascular · 172d

Cleared Mar 27, 2014

MANDREL GUIDEWIRE

Cardiovascular · 29d

Cleared Nov 03, 2011

HI TORQUE CONNECT GUIDEWIRE

Cardiovascular · 78d

Cleared Aug 02, 2011

ANCHORWIRE GUIDEWIRE

Cardiovascular · 88d