Class Class II
8F Modified Sheath System (K240529)
Description
8F Modified Sheath System by Route 92 Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240529
Clearance Date2024-10-02
Clearance TypeSpecial
Product CodeQJP
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240529
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. 8F Modified Sheath System (K240529) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191717 | Route 92 Medical Sheath System | Route 92 Medical, Inc. | 2020 |
Trace the full predicate network for K240529
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.