K254248
- 510(k) number
- K254248
- Device name
- Introducer Sheath Set
- Applicant
- Cardiocycle Medical(Suzhou) Co., Ltd. CN
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-23
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254248.pdf
Official FDA record: K254248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.