Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K070213 |
Device Name |
PERFORMER CBP SYSTEM |
Applicant |
RAND S.R.L. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
PREETI JAIN |
Correspondent |
RAND S.R.L. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
PREETI JAIN |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 01/22/2007 |
Decision Date | 03/21/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|