Device Classification Name |
Tubing, Pump, Cardiopulmonary Bypass
|
510(k) Number |
K053025 |
Device Name |
JOSTRA HLM TUBING SET |
Applicant |
MAQUET CARDIOPULMONARY AG |
P.O. BOX 2042 |
FAIRFIELD,
IA
52556
|
|
Applicant Contact |
KATHLEEN JOHNSON |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 870.4390
|
Classification Product Code |
|
Date Received | 10/27/2005 |
Decision Date | 11/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|