Class Class II
VersaD Delivery Catheter (K242051)
Description
VersaD Delivery Catheter by Unity Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242051
Clearance Date2025-01-17
Clearance TypeTraditional
Product CodeQJP
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242051
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. VersaD Delivery Catheter (K242051) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020 |
Trace the full predicate network for K242051
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.