K232260
- 510(k) number
- K232260
- Device name
- Thinline Sheath Introducer
- Applicant
- Inneuroco, Inc. FL · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2023-09-27
- Date received
- 2023-07-31
- 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: K232260.pdf
Official FDA record: K232260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.