510(k) Report

Devices descending from K050015

4 later devices reach Modified Acumen Sheath, Model TTWO767 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051515Modified Acumen Sheath, Model TTW 10-65Acumen Medical, Inc.20053—
+2K062145Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and…Acumen Medical, Inc.20062—
+3K070197Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-StyAcumen Medical, Inc.20071—
+4K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc.20090—