TERUMO PALL AL20X ARTERIAL FILTER


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K121209
Device Name TERUMO PALL AL20X ARTERIAL FILTER
Applicant
Terumo Cardiovascular Systems Corporation
125 blue ball rd.
elkton, 
MD 
21921

Applicant Contact suzanne grenier
Correspondent
Terumo Cardiovascular Systems Corporation
125 blue ball rd.
elkton, 
MD 
21921

Correspodent Contact suzanne grenier
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 04/20/2012
Decision Date 05/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No