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407
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214
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Shanghai Heartcare Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shanghai
Shanghai Heartcare Medical Technology Co., Ltd. - FDA 510(k) Cleared ...
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shanghai Heartcare Medical Technology Co., Ltd.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 22, 2023
Distal Access Catheter
K233205
·
QJP
Neurology
·
85d
Cleared
Feb 10, 2022
Micro Catheter
K202926
·
QJP
Neurology
·
499d
Cleared
Aug 25, 2021
Balloon Guiding Catheter
K202916
·
QJP
Neurology
·
330d
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3
Neurology
3