CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K002238
Device Name CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton, 
MD 
21921

Original Contact garry a courtney
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 07/24/2000
Decision Date 08/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No