K243493
- 510(k) number
- K243493
- Device name
- Agilis NxT Steerable Introducer Dual-Reach
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-12-13
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243493.pdf
Official FDA record: K243493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.