Class Class II
SafeCross Vascular Introducer System (4001) (K240600)
Description
SafeCross Vascular Introducer System (4001) by East End Medical I, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240600
Clearance Date2024-09-06
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240600
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. SafeCross Vascular Introducer System (4001) (K240600) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203459 | SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC | 2021 |
| K151951 | Destino Reach | Oscor, Inc. | 2015 |
Trace the full predicate network for K240600
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.