Lumend, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 21, 2005

MODIFICATION TO OUTBACK CATHETER

K043534 · DQY

Cardiovascular · 30d

Cleared Apr 23, 2004

MODIFICATION TO OUTBACK CATHETER

K040771 · DQY

Cardiovascular · 29d

Cleared Jan 07, 2004

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

K033535 · PDU

Cardiovascular · 58d

Cleared Aug 26, 2003

MODIFICATION TO OUTBACK CATHETER

K032298 · DQY

Cardiovascular · 32d

Cleared Jun 18, 2003

LUMEND FRONTRUNNER GW CTO CATHETER

K031005 · PDU

Cardiovascular · 79d

Cleared Jan 23, 2003

LUMEND FRONTRUNNER CTO CATHETER

K023114 · PDU

Cardiovascular · 126d

Cleared Oct 24, 2002

MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER

K023223 · DQY

Cardiovascular · 27d

Cleared Feb 11, 2002

LUMEND FRONTRUNNER CTO CORONARY CATHETER

K013284 · DQY

Cardiovascular · 132d

Cleared Jan 16, 2002

LUMEND PERCUTANEOUS CATHETER

K011562 · DQY

Cardiovascular · 240d

Cleared Jan 11, 2002

MODIFICATION TO OUTBACK CATHETER

K014117 · DQY

Cardiovascular · 28d

Cleared Jan 11, 2001

OUTBACK CATHETER

K001577 · DQY

Cardiovascular · 234d