ABBOTT MEDICAL · Class II · Cleared May 23, 2025
| 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 |
| Product code | OBJ |
| Device class | Class II |
| Decision date | May 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1200 |
This 510(k) submission covers six cardiac devices: ViewFlex Xtra and Eco Reprocessed ICE catheters for intracardiac ultrasound visualization of cardiac structures and blood flow; Advisor HD Grid and HD Grid X mapping catheters for high-density electrophysiological mapping; and Agilis NxT steerable introducers for catheter positioning during cardiac arrhythmia treatment. All devices are intended for use in adult and adolescent pediatric patients during electrophysiology procedures.
All technological characteristics are identical between the subject devices and their respective predicate devices—no design changes were proposed. The modifications consist solely of clarifications to the Agilis NxT indications for use statement to reflect zero/low fluoroscopy clinical workflows, without altering the device functionality, materials, or specifications.
Not stated in this summary.
Substantial equivalence is claimed based on identical technological characteristics and indications for use between subject and predicate devices. The submission argues that clarifying the Agilis NxT indications to reflect zero/low fluoroscopy workflow does not introduce new intended use or raise different safety/effectiveness questions. Clinical data from multiple studies using alternative visualization methods are cited to support equivalence, though bench-testing was deemed unnecessary since no device modifications were made.
View the full FDA submission: accessdata.fda.gov