Device Classification Name |
mechanical thrombolysis catheter
|
510(k) Number |
K183361 |
Device Name |
EkoSonic Endovascular Device with Control Unit 4.0 |
Applicant |
BTG International, Inc. |
11911 N Creek Pkwy S |
Bothell,
WA
98011
|
|
Applicant Contact |
Benjamin Hornsey |
Correspondent |
BTG International, Inc. |
11911 N Creek Pkwy S |
Bothell,
WA
98011
|
|
Correspondent Contact |
Benjamin Hornsey |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/04/2018 |
Decision Date | 04/05/2019 |
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
|
|
|