Class Class II
ViewFlex™ Eco Reprocessed ICE Catheter (K230934)
Description
ViewFlex™ Eco Reprocessed ICE Catheter by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230934
Clearance Date2023-05-03
Clearance TypeSpecial
Product CodeOWQ
Regulation Number870.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230934
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™ Eco Reprocessed ICE Catheter (K230934) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | 2022 |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medic... | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231588 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023 |
Trace the full predicate network for K230934
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.