K241230
- 510(k) number
- K241230
- Device name
- Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
- Applicant
- Togo Medikit Co., Ltd. JP
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-09-17
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241230.pdf
Official FDA record: K241230
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.