Introducer Sheath Set— 510(k) K254248
Substantially EquivalentCardiocycle Medical(Suzhou) Co., Ltd.
FDA 510(k) clearance K254248 for Introducer Sheath Set, Substantially Equivalent on 2026-04-23. Applicant: Cardiocycle Medical(Suzhou) Co., Ltd.. Device class: 2.
Summary
Cardiocycle Medical (Suzhou)'s Introducer Sheath Set is filed under product code DYB (Introducer, Catheter). The name is generic.
Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Cardiocycle Medical filed from Suzhou, Jiangsu, China. The record shows 115 calendar days from receipt to decision (December 29, 2025 to April 23, 2026).
Clearance details
- Applicant
- Cardiocycle Medical(Suzhou) Co., Ltd.
- Product code
- Product code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, Jiangsu, CN
Recent devices under product code DYB
view allMore clearances from Cardiocycle Medical(Suzhou) Co., Ltd.
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.