Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826)
Description
Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter by Sterilmed, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240826
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. Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® M... | Biosense Webster, Inc. | 2023 |
| K101991 | WEBSTER DUO-DECAPOLAR CATHETER | Biosense Webster, Inc. | 2011 |
| K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND... | Biosense Webster, Inc. | 2008 |
Trace the full predicate network for K240826
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.