Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503)
Description
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable by Boston Scientific, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230503
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. Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081576 | BLAZER DX-20 DIAGNOSTIC CATHETER | Boston Scientific Corp | 2009 |
Trace the full predicate network for K230503
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.