Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K864585 |
Device Name |
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
1395 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
MARIANNA FAIST |
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
1395 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
MARIANNA FAIST |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/17/1986 |
Decision Date | 12/05/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|