Device Classification Name |
mechanical thrombolysis catheter
|
510(k) Number |
K060422 |
Device Name |
LYSUS INFUSION SYSTEM |
Applicant |
EKOS CORP. |
22030 20TH AVENUE S.E. |
SUITE 101 |
BOTHELL,
WA
98021
|
|
Applicant Contact |
JOCELYN KERSTEN |
Correspondent |
EKOS CORP. |
22030 20TH AVENUE S.E. |
SUITE 101 |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
JOCELYN KERSTEN |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/17/2006 |
Decision Date | 03/09/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|