# K251211: 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™

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: May 23, 2025 after 35 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K000248 (2000). 70 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223077: ViewFlex Xtra ICE Catheter, Irvine Biomedical, A St. Jude Medical Company (2022) Summary page 6.
- K231588: ViewFlex™ Eco Reprocessed ICE Catheter, Abbott Medical (2023) Summary page 7.
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled, Abbott Medical (2020) Summary page 7.
- K241372: Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, Abbott Medical (2024) Summary page 8.
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 9.
- K243493: Agilis NxT Steerable Introducer Dual-Reach, Abbott Medical (2024) Summary page 9.

## Most influential descendants
- K250305: Reprocessed Agilis NxT Steerable Introducer (2026), 0 descendants of its own
- K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (2025), 0 descendants of its own

## Indications for use
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart. The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart. The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias. The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Source page: https://510kreport.com/device/K251211
Methodology: https://510kreport.com/methodology