Device Classification Name |
Catheter, Ultrasound, Intravascular
|
510(k) Number |
K160583 |
Device Name |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
Applicant |
VOLCANO CORPORATION |
3721 VALLEY CENTRE DRIVE SUITE 500 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
BRIAN PARK |
Correspondent |
VOLCANO CORPORATION |
3721 VALLEY CENTRE DRIVE SUITE 500 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
BRIAN PARK |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2016 |
Decision Date | 10/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|