Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K130209 |
Device Name |
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED |
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
|
|
Correspondent Contact |
SCOTT LIGHT |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 01/29/2013 |
Decision Date | 02/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|