Class Class II
Branchor X Balloon Guide Catheter (K251240)
Description
Branchor X Balloon Guide Catheter by Asahi Intecc Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251240
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeQJP
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251240
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. Branchor X Balloon Guide Catheter (K251240) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2022 |
| K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2021 |
| K120781 | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH | Fuji Systems Corp. | 2012 |
Trace the full predicate network for K251240
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.