Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K060016 |
Device Name |
THROMCAT THROMBECTOMY CATHETER SYSTEM |
Applicant |
KENSEY NASH CORP. |
735 PENNSYLVANIA AVE. |
EXTON,
PA
19341
|
|
Applicant Contact |
JENNIFER J BOSLEY |
Correspondent |
KENSEY NASH CORP. |
735 PENNSYLVANIA AVE. |
EXTON,
PA
19341
|
|
Correspondent Contact |
JENNIFER J BOSLEY |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 01/03/2006 |
Decision Date | 04/25/2006 |
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
|
|
|