CAPIOX ARTERIAL FILTER


the company

Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K002026
Device Name CAPIOX ARTERIAL FILTER
Original Applicant
TERUMO MEDICAL CORP.
125 blue ball rd.
elkton, 
MD 
21921

Original Contact garry a courtney
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 07/03/2000
Decision Date 09/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No