Class Class II
Primum Hydrophilic Guiding Catheter (K250972)
Description
Primum Hydrophilic Guiding Catheter by Pendracare, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250972
Clearance Date2025-06-29
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250972
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. Primum Hydrophilic Guiding Catheter (K250972) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K132197 | CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER | Pendracare International, B.V. | 2013 |
| K120585 | CONVEY GUIDING CATHETER | Pendracare International, B.V. | 2012 |
Trace the full predicate network for K250972
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.