CAPIOX CARDIOTOMY RESERVOIR


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K030505
Device Name CAPIOX CARDIOTOMY RESERVOIR
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton, 
MD 
21921

Applicant Contact garry a courtney
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton, 
MD 
21921

Correspodent Contact garry a courtney
Regulation Number 870.2100
Classification Product Code
DPW  
Date Received 02/19/2003
Decision Date 05/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No