Device Classification Name |
Transducer, Pressure, Catheter Tip
|
510(k) Number |
K070487 |
Device Name |
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX |
Applicant |
VOLCANO CORPORATION |
2870 KILGORE RD. |
RANCHO CORDOVA,
CA
95670
|
|
Applicant Contact |
CYNTHIA VAN DUKER |
Correspondent |
VOLCANO CORPORATION |
2870 KILGORE RD. |
RANCHO CORDOVA,
CA
95670
|
|
Correspondent Contact |
CYNTHIA VAN DUKER |
Regulation Number | 870.2870
|
Classification Product Code |
|
Date Received | 02/20/2007 |
Decision Date | 03/16/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|