510(k) Report

Devices descending from K110315

6 later devices reach Nexgen Peripheral Mechanical Retrieval Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192814Pounce Thrombus Retrieval SystemSurmodics,Inc.20205—
+2K211492Pounce Thrombectomy SystemSurmodics,Inc.20214—
+3K220501Pounce Thrombectomy SystemSurmodics,Inc.20223—
+4K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc.20240—
+4K231022Pounce™ Thrombectomy SystemSurmodics,Inc.20232—
+5K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.20260—