Class Class II
ShapeIT (SI014135) (K241611)
Description
ShapeIT (SI014135) by Imds Operations B.V., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241611
Clearance Date2024-09-03
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241611
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. ShapeIT (SI014135) (K241611) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223728 | Micro Rx | Imds Operations B.V. | 2023 |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, Supe... | Vascular Solutions, LLC | 2021 |
| K182570 | Venture 0.014 Catheter | Vascular Solutions, LLC | 2019 |
Trace the full predicate network for K241611
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.