510(k) Report

Devices descending from K070197

1 later device reach Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc.20090—