Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K021694 |
Device Name |
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 |
Applicant |
CARDIOVENTION, INC. |
3045 STENDER WAY |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
TESSA YAMUT |
Correspondent |
CARDIOVENTION, INC. |
3045 STENDER WAY |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
TESSA YAMUT |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 05/22/2002 |
Decision Date | 01/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|