Class Class II
DLP™ Silicone Coronary Artery Ostial Cannulae (K230960)
Description
DLP™ Silicone Coronary Artery Ostial Cannulae by Medtronic, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230960
Clearance Date2023-05-04
Clearance TypeSpecial
Product CodeDWF
Regulation Number870.4210
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230960
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. DLP™ Silicone Coronary Artery Ostial Cannulae (K230960) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141951 | DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE | Medtronic, Inc. | 2014 |
Trace the full predicate network for K230960
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.