Data / Medical devices / China / Cardiocycle Medical(suzhou) Co.,ltd.
Cardiocycle Medical(suzhou) Co.,ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 2 510(k) clearances
Cardiocycle Medical(suzhou) Co.,ltd. is registered with the FDA (registration 3042279517) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042279517
- Address
- Unit 401&501, Building C15, Stage 5, BioBAY, No.21 Chaoqian Road, Suzhou Industrial Park, Suzhou Jiangsu, China, 215000
- Owner or operator
- Cardiocycle Medical(Suzhou) Co.,Ltd. (10094401)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 26, 2025
- Registered through
- 2026
- Brand names listed
- CorPass
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Catheter | DYB | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 23, 2026 | K254248 | Introducer Sheath Set | DYB | Substantially Equivalent | Cardiocycle Medical(Suzhou) Co., Ltd. | accessdata.fda.gov |
| October 21, 2025 | K251838 | Introducer Sheath Set | DYB | Substantially Equivalent | Cardiocycle Medical(Suzhou) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 2026. 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.