Class Class II
ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231)
Description
ViewFlex™ X ICE Catheter, Sensor Enabled™ by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251231
Clearance Date2025-05-20
Clearance TypeSpecial
Product CodeOBJ
Regulation Number870.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251231
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™ X ICE Catheter, Sensor Enabled™ (K251231) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medic... | 2022 |
Trace the full predicate network for K251231
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.