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™ (K251211)
Description
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™ by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251211
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 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™ (K251211) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | 2024 |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | 2024 |
| K231588 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023 |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medic... | 2022 |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, S... | ABBOTT MEDICAL | 2020 |
| K061363 | AGILIS NXT STEERABLE INTRODUCER | St Jude Medical | 2006 |
Trace the full predicate network for K251211
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.