Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K121301 |
Device Name |
XPRESSWAY RX CATHETER (6F LD-VERISON) |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 FIFTH AVE., 21ST FLOOR |
NEW YORK,
NY
10036
|
|
Applicant Contact |
JOSEPH DEPAOLO |
Correspondent |
KANEKA PHARMA AMERICA LLC |
546 FIFTH AVE., 21ST FLOOR |
NEW YORK,
NY
10036
|
|
Correspondent Contact |
JOSEPH DEPAOLO |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 05/01/2012 |
Decision Date | 07/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|