LUMEND FRONTRUNNER CTO CATHETER


Device Classification Name

catheter for crossing total occlusions

510(k) Number K023114
Device Name LUMEND FRONTRUNNER CTO CATHETER
Original Applicant
LUMEND, INC.
400 chesapeake dr.
redwood city, 
CA 
94063

Original Contact michael a daniel
Regulation Number 870.1250
Classification Product Code
PDU  
Subsequent Product Code
DQY  
Date Received 09/19/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No