Lake Region Medical - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Lake Region Medical has 16 FDA 510(k) cleared cardiovascular devices. Based in Chaska, US.
Latest FDA clearance: Mar 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
16 devices
Cleared
Mar 19, 2026
Enroute 0.014'' Transcarotid Guidewire
Cardiovascular
114d
Cleared
Dec 06, 2024
PTFE Guidewire
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
Sep 19, 2014
Predicate III Guidewire
Gastroenterology & Urology
23d
Cleared
Apr 08, 2014
MANDREL GUIDEWIRE
Gastroenterology & Urology
41d
Cleared
Apr 07, 2014
HYDROPHILIC COATED GUIDEWIRE
Cardiovascular
172d
Cleared
Mar 27, 2014
MANDREL GUIDEWIRE
Cardiovascular
29d
Cleared
Feb 26, 2013
OSTAVI HYDROPHILIC GUIDEWIRE
Gastroenterology & Urology
57d
Cleared
Nov 03, 2011
HI TORQUE CONNECT GUIDEWIRE
Cardiovascular
78d
Cleared
Aug 02, 2011
ANCHORWIRE GUIDEWIRE
Cardiovascular
88d
Cleared
Mar 21, 2008
MANDREL GUIDEWIRES OR M-WIRE
Gastroenterology & Urology
25d