Device Classification Name |
Console, Heart-Lung Machine, Cardiopulmonary Bypass
|
510(k) Number |
K103762 |
Device Name |
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE |
Applicant |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON, RN, MED, RAC |
Correspondent |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON, RN, MED, RAC |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 12/23/2010 |
Decision Date | 01/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|