Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K121229 |
Device Name |
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY |
Applicant |
SORIN GROUP ITALIA S.R.L. |
195 WEST STREET |
WALTHAM,
MA
02451
|
|
Applicant Contact |
BARRY SALL |
Correspondent |
SORIN GROUP ITALIA S.R.L. |
195 WEST STREET |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
BARRY SALL |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 04/24/2012 |
Decision Date | 07/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|