Device Classification Name |
mechanical thrombolysis catheter
|
510(k) Number |
K200648 |
Device Name |
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) |
Applicant |
EKOS Corporation |
11911 North Creek Parkway S |
Bothell,
WA
98011
|
|
Applicant Contact |
Joshua Kim |
Correspondent |
EKOS Corporation |
11911 North Creek Parkway S |
Bothell,
WA
98011
|
|
Correspondent Contact |
Joshua Kim |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2020 |
Decision Date | 08/17/2020 |
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
|