Device Classification Name |
Reprocessed Intravascular Ultrasound Catheter
|
510(k) Number |
K121913 |
Device Name |
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER |
Applicant |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
10232 S. 51st St. |
Phoenix,
AZ
85044
|
|
Applicant Contact |
MOIRA BARTON-VARTY |
Correspondent |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
10232 S. 51st St. |
Phoenix,
AZ
85044
|
|
Correspondent Contact |
MOIRA BARTON-VARTY |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 12/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|