CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K022115
Device Name CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
Original Applicant
TERUMO CORP.
125 blue ball rd.
elkton, 
MD 
21921

Original Contact garry a courtney
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 07/01/2002
Decision Date 09/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No