Class Class II
DualView Catheter (K250751)
Description
DualView Catheter by Terumo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250751
Clearance Date2025-07-17
Clearance TypeTraditional
Product CodeDQO
Regulation Number870.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250751
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. DualView Catheter (K250751) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | Lightlab Imaging, Inc. | 2014 |
| K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | Boston Scientific Corp | 2013 |
Trace the full predicate network for K250751
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.