Device Classification Name |
peripheral mechanical thrombectomy with aspiration
|
510(k) Number |
K182835 |
Device Name |
WOLF Thrombectomy Device |
Applicant |
880 Medical, LLC |
46714 Fremont Blvd. |
Fremont,
CA
94538
|
|
Applicant Contact |
Micheal P. Wallace |
Correspondent |
Northwest Clinical Research Group, Inc. |
19836 NE 125th Place |
Woodinville,
WA
98077
|
|
Correspondent Contact |
Roberta Hines |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 10/09/2018 |
Decision Date | 03/27/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|