510(k) Report

Devices descending from K103405

4 later devices reach Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+2K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+3K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+4K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—