Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K100930 |
Device Name |
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J |
Applicant |
VOLCANO CORPORATION |
3661 VALLEY CENTER DR |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
MARILYN POURAZAR |
Correspondent |
VOLCANO CORPORATION |
3661 VALLEY CENTER DR |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
MARILYN POURAZAR |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 04/05/2010 |
Decision Date | 04/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|