510(k) Report

Devices descending from K190941

1 later device reach BioCardia 8.5 F Avance Steerable lntroducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202226Lim Precision Steerable TS, Steerable Sheath, DilatorKeystone Heart, Ltd.20200—