Device Classification Name |
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
|
510(k) Number |
K123448 |
Device Name |
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE |
Applicant |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
JULIA A NELSON |
Correspondent |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
JULIA A NELSON |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 11/08/2012 |
Decision Date | 12/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|