CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311)
Description
CPS Direct™ Universal slittable outer guide catheter (DS2C029) by Abbott Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231311
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. CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER | St Jude Medical | 2013 |
Trace the full predicate network for K231311
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.