Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
More FDA Info for this Device |
510(K) Number |
K214009 |
Device Name |
Catheter, Angioplasty, Peripheral, Transluminal |
Applicant |
DK Medical Technology Co., Ltd.
301 unit, bioBAY B1, 218 Xinghu Str., Suzhou Industrial Park
Suzhou 215123 CN
Other 510(k) Applications for this Company
|
Contact |
Shi Quan
Other 510(k) Applications for this Contact |
Regulation Number |
870.1250
More FDA Info for this Regulation Number |
Classification Product Code |
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/05/2021 |
Decision Date |
04/05/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|