510(k) Report

Devices descending from K101615

2 later devices reach Powerwire Radiofrequency Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+2K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—