Data / Medical devices / China / Shanghai Heartcare Medical Technology Corporation Limited
Shanghai Heartcare Medical Technology Corporation Limited: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Shanghai Heartcare Medical Technology Corporation Limited is registered with the FDA (registration 3024801436) in Shanghai, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024801436
- Address
- Building 38, No.356 Zhengbo Road, LIN-GANG Special Area China(Shanghai) Pilot Free Trade Zone, 201422 Shanghai, China, Shanghai, China, 201422
- Owner or operator
- Shanghai HeartCare Medical Technology Corporation Limited (10087291)
- Roles
- Manufacturer
- First device listed
- February 9, 2023
- Registered through
- 2026
- Brand names listed
- Balloon Guiding Catheter, Distal Access Catheter, Micro Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2023 | K233205 | Distal Access Catheter | QJP | Substantially Equivalent | Shanghai Heartcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 10, 2022 | K202926 | Micro Catheter | QJP | Substantially Equivalent | Shanghai Heartcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 25, 2021 | K202916 | Balloon Guiding Catheter | QJP | Substantially Equivalent | Shanghai Heartcare Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.