510(k) Report

Devices descending from K220501

3 later devices reach Pounce Thrombectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc.20240—
+1K231022Pounce™ Thrombectomy SystemSurmodics,Inc.20232—
+2K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.20260—