Class Class II
TriClip Steerable Guide Catheter (K241538)
Description
TriClip Steerable Guide Catheter by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241538
Clearance Date2024-08-26
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241538
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. TriClip Steerable Guide Catheter (K241538) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | 2022 |
| K131063 | AMPLATZER TORQ VUE LP DELIVERY SYSTEM | St Jude Medical | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ ... | ABBOTT MEDICAL | 2024 |
Trace the full predicate network for K241538
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.