510(k) Report

Devices descending from K192833

5 later devices reach Indigo Aspiration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc.20240—
+1K220270Aspirex Thrombectomy SystemC.R. Bard, Inc.20221—
+1K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+1K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+2K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc.20230—