Device Classification Name |
catheter, intravascular occluding, temporary
|
510(k) Number |
K210602 |
Device Name |
AortaSTAT Occlusion Device |
Applicant |
RenalPro Medical, Inc. |
2370-B Walsh Avenue |
Santa Clara,
CA
95051
|
|
Applicant Contact |
James Twitchell |
Correspondent |
Northwest Clinical Research Group, Inc. |
19836 NE 125th Place |
Woodinville,
WA
98077
|
|
Correspondent Contact |
Roberta Hines |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 03/01/2021 |
Decision Date | 07/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|