510(k) Report

Devices descending from K982232

6 later devices reach Modification of the Ibi-1100 Steerable Electrophysiology Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.20240Class I
+1K203261Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC20210—
+1K171277Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC20171—
+1K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions20110—
+1K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20100—
+1K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20081—