CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K080774
Device Name CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
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 870.4360
Classification Product Code
KFM  
Date Received 03/19/2008
Decision Date 04/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes