ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K080360
Device Name ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
Applicant
ENDOLOGIX, INC.
11 studebaker
irvine, 
CA 
92618

Applicant Contact annaliza victoria
Correspondent
ENDOLOGIX, INC.
11 studebaker
irvine, 
CA 
92618

Correspodent Contact annaliza victoria
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 02/11/2008
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No