K241370
- 510(k) number
- K241370
- Device name
- Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-06-13
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241370.pdf
Official FDA record: K241370
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.