510(k) Report

Devices descending from K964663

15 later devices reach Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053300SyvekexcelMarine Polymer Technologies, Inc.200614—
+2K072890Stasilon FREntegrion, Inc.20075—
+2K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.200613—
+3K142363Nustat, Nustat XRBeeken Biomedical20154—
+3K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K160578Nustat XRBeeken Biomedical, LLC20160—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K181641QuikClot RadialZ-Medica, LLC20180—