510(k) Report

Devices descending from K234115

4 later devices reach APRO 55 Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251014APRO 45 CatheterAlembic, LLC20251—
+1K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+1K243297APRO 70 Swift CatheterAlembic, LLC20250—
+2K262392APRO 35 Swift CatheterAlembic, LLC20260—