Class Class II
Angiography Injector (K242143)
Description
Angiography Injector by Shandong Int Medical Instruments Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242143
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeDXT
Regulation Number870.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242143
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. Angiography Injector (K242143) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017 |
Trace the full predicate network for K242143
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.