Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K955175 |
Device Name |
ACS ANCHOR EXCHANGE DEVICE |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
26351 YNEZ RD. |
TEMECULA,
CA
92591 -4628
|
|
Applicant Contact |
JOY TAN |
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
26351 YNEZ RD. |
TEMECULA,
CA
92591 -4628
|
|
Correspondent Contact |
JOY TAN |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/13/1995 |
Decision Date | 04/05/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|