Cardiocycle Medical(Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 1 device type, 2 clearances.
Cardiocycle Medical(Suzhou) Co., Ltd. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Introducer, Catheter. Its earliest product listing with the FDA dates from 2025.
1device type
2510(k) clearances
Registration
| Registered name | CARDIOCYCLE MEDICAL(SUZHOU) CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3042279517 |
| FEI number | 3042279517 |
| Establishment type | Complaint-file establishment, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Unit 401&501, Building C15, Stage 5, BioBAY, No.21 Chaoqian Road, Suzhou Industrial Park |
| Postal code | 215000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Introducer, Catheter | Class 2 | CorPass | 2025 | 13 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254248 | 2026-04-23 | DYB | Traditional | This company |
| K251838 | 2025-10-21 | DYB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2021 |
|---|---|
| Factory area | 4000 |
| Main products | interventional oncology devices, interventional cardiology devices, neurointerventional products |
| Certifications | Class III medical device registration, ISO 13485 |
| Export markets | Multiple countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.