Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K911957 |
Device Name |
ACS RX SUPPORT CATHETER |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
26531 YNEZ RD. |
TEMECULA,
CA
92591
|
|
Applicant Contact |
KEVIN CORRIGAN |
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
26531 YNEZ RD. |
TEMECULA,
CA
92591
|
|
Correspondent Contact |
KEVIN CORRIGAN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 05/02/1991 |
Decision Date | 09/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|