Class Class II
VasoGuard (V10, V8, V6, V4, V2) (K233976)
Description
VasoGuard (V10, V8, V6, V4, V2) by Corvascular Diagnostics, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233976
Clearance Date2024-07-19
Clearance TypeTraditional
Product CodeJOP
Regulation Number870.2880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233976
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. VasoGuard (V10, V8, V6, V4, V2) (K233976) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111416 | FALCON | Viasonix , Ltd. | 2011 |
Trace the full predicate network for K233976
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.