OPTION VENA CAVA FILTER


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K081410
Device Name OPTION VENA CAVA FILTER
Applicant
REX MEDICAL
386 w. main street
suite 7
northborough, 
MA 
01532

Applicant Contact leo basta
Correspondent
REX MEDICAL
386 w. main street
suite 7
northborough, 
MA 
01532

Correspodent Contact leo basta
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 05/20/2008
Decision Date 06/04/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No