INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K121536
Device Name INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
Applicant
SORIN GROUP ITALIA S.R.L.
14401 w. 65th way
arvada, 
CO 
80004

Applicant Contact scott light
Correspondent
SORIN GROUP ITALIA S.R.L.
14401 w. 65th way
arvada, 
CO 
80004

Correspodent Contact scott light
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 05/24/2012
Decision Date 08/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No