510(k) Report

Devices descending from K181828

2 later devices reach Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231—
+2K244061X-Wire GuidewireImperative Care, Inc.20250—