K261950
- 510(k) number
- K261950
- Device name
- Health Line Tearaway Introducer
- Applicant
- Health Line International Corporation UT · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-06-22
- Date received
- 2026-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261950.pdf
Official FDA record: K261950
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.