510(k) Report

Devices descending from K042553

3 later devices reach Biocardia Morph Universal Deflectable Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia20201—
+1K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+2K242169Morph DNA Steerable Introducer SheathBiocardia20240—