Device Classification Name |
Catheter, Percutaneous, Neurovasculature
|
510(k) Number |
K233205 |
Device Name |
Distal Access Catheter |
Applicant |
Shanghai HeartCare Medical Technology Co.,Ltd. |
590 Ruiqing Rd, Building 4, Suite 201, |
East Zhangjiang High-Tech Park |
Shanghai,
CN
201201
|
|
Applicant Contact |
Tianrong Hong |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 12/22/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|