Class Class II
PeriCross™ Epicardial Access Kit (K243954)
Description
PeriCross™ Epicardial Access Kit by Circa Scientific, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243954
Clearance Date2025-04-24
Clearance TypeTraditional
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243954
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. PeriCross™ Epicardial Access Kit (K243954) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | 2024 |
| K111943 | AGILLS PF DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Ma... | 2011 |
| K031691 | MERIT MAK (MINI ACCESS KIT) | Merit Medical Systems, Inc. | 2003 |
Trace the full predicate network for K243954
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.