Device Classification Name |
Console, Heart-Lung Machine, Cardiopulmonary Bypass
|
510(k) Number |
K022947 |
Device Name |
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
MARK A BUR |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
MARK A BUR |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 09/05/2002 |
Decision Date | 03/20/2003 |
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
|
|
|