510(k) Report

Devices descending from K211492

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220501Pounce Thrombectomy SystemSurmodics,Inc.20223—
+2K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc.20240—
+2K231022Pounce™ Thrombectomy SystemSurmodics,Inc.20232—
+3K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.20260—