K251211
- 510(k) number
- K251211
- Device name
- ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2025-05-23
- Date received
- 2025-04-18
- 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: K251211.pdf
Official FDA record: K251211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.