CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K023116
Device Name CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
Original Applicant
CORDIS CORP.
7 powder horn dr.
warren, 
NJ 
07059

Original Contact karen wilk
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 09/19/2002
Decision Date 10/18/2002
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No