FDA applicant
Cardiocycle Medical (Suzhou) Co., Ltd.
FDA records 2 decisions for Cardiocycle Medical (Suzhou) Co., Ltd. (Suzhou, Jiangsu, CN) from 2025 to 2026: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardiocycle Medical (Suzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Cardiocycle Medical (Suzhou) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report