Device Classification Name |
device, counter-pulsating, external
|
510(k) Number |
K050172 |
Device Name |
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 |
Applicant |
CARDIOMEDICS, INC. |
18872 BARDEEN AVE. |
IRVINE,
CA
92612
|
|
Applicant Contact |
JOHN HUTCHINS |
Correspondent |
CARDIOMEDICS, INC. |
18872 BARDEEN AVE. |
IRVINE,
CA
92612
|
|
Correspondent Contact |
JOHN HUTCHINS |
Regulation Number | 870.5225
|
Classification Product Code |
|
Date Received | 01/26/2005 |
Decision Date | 03/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|