LBI EMBOLECTOMY SYSTEM


Device Classification Name

catheter, embolectomy

510(k) Number K080901
Device Name LBI EMBOLECTOMY SYSTEM
Applicant
LUMEN BIOMEDICAL, INC.
14505 21st ave. north
suite 212
plymouth, 
MN 
55447

Applicant Contact maria e brittle
Correspondent
LUMEN BIOMEDICAL, INC.
14505 21st ave. north
suite 212
plymouth, 
MN 
55447

Correspodent Contact maria e brittle
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 03/31/2008
Decision Date 10/02/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No