Lumend, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO OUTBACK CATHETER, MODIFICATION TO OUTBACK CATHETER, LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lumend, Inc. Cardiovascular ✕
11 devices
Cleared
Jan 21, 2005
MODIFICATION TO OUTBACK CATHETER
Cardiovascular
30d
Cleared
Apr 23, 2004
MODIFICATION TO OUTBACK CATHETER
Cardiovascular
29d
Cleared
Jan 07, 2004
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
Cardiovascular
58d
Cleared
Aug 26, 2003
MODIFICATION TO OUTBACK CATHETER
Cardiovascular
32d
Cleared
Jun 18, 2003
LUMEND FRONTRUNNER GW CTO CATHETER
Cardiovascular
79d
Cleared
Jan 23, 2003
LUMEND FRONTRUNNER CTO CATHETER
Cardiovascular
126d
Cleared
Oct 24, 2002
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
Cardiovascular
27d
Cleared
Feb 11, 2002
LUMEND FRONTRUNNER CTO CORONARY CATHETER
Cardiovascular
132d
Cleared
Jan 16, 2002
LUMEND PERCUTANEOUS CATHETER
Cardiovascular
240d
Cleared
Jan 11, 2002
MODIFICATION TO OUTBACK CATHETER
Cardiovascular
28d
Cleared
Jan 11, 2001
OUTBACK CATHETER
Cardiovascular
234d