510(k) Report

Devices descending from K192814

5 later devices reach Pounce Thrombus Retrieval System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211492Pounce Thrombectomy SystemSurmodics,Inc.20214—
+2K220501Pounce Thrombectomy SystemSurmodics,Inc.20223—
+3K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc.20240—
+3K231022Pounce™ Thrombectomy SystemSurmodics,Inc.20232—
+4K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.20260—