Class Class II
Pantera Pro; Pantera LEO (K242969)
Description
Pantera Pro; Pantera LEO by Biotronik, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242969
Clearance Date2024-10-25
Clearance TypeSpecial
Product CodeLOX
Regulation Number870.5100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242969
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. Pantera Pro; Pantera LEO (K242969) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163660 | Pantera LEO | Biotronik, Inc. | 2017 |
| K160985 | Pantera Pro | Biotronik, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Per... | Biotronik, Inc. | 2025 |
Trace the full predicate network for K242969
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.