510(k) Report

Devices descending from K990958

3 later devices reach Orthogonal EP Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions20110—
+1K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20100—
+1K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20081—