C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457)
Description
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) by Pentax of America, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240457
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. C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022 |
| K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021 |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | Barrx Medical, Incorporated | 2010 |
Trace the full predicate network for K240457
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.