510(k) Report

Devices descending from K012293

45 later devices reach Vascular Solutions Duett Flowable Hemostat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070938Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatVascular Solutions, Inc.20070—
+1K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc.2003443
+2K073264D-Stat Dry Clear Hemostatic Bandage, Model 3005Vascular Solutions, Inc.20073—
+2K072117Thrombix Patch Thrombin Hemostasis PatchVascular Solutions, Inc.20072—
+2K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.200613—
+2K053300SyvekexcelMarine Polymer Technologies, Inc.200614—
+2K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc.200516—
+2K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.200525—
+2K050133D-Stat Radial Hemostatic BandVascular Solutions, Inc.20052—
+2K040118Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and…Vascular Solutions, Inc.20040—
+3K200720D-Stat Radial Topical HemostatVascular Solutions, LLC20200—
+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—
+3K092612D-Stat Rad-Band, Rad-Band, Models 3501, 3505Vascular Solutions, Inc.20090—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K083190D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Vascular Solutions, Inc.20081—
+3K072890Stasilon FREntegrion, Inc.20075—
+3K072900Excelarrest FoamHemostasis, LLC200719—
+3K063871D-Stat Handle, Model 8500-053Vascular Solutions, Inc.20070—
+3K063860Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20072—
+3K053644Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20063—
+3K053054Thrombix 3X3 Hemostatic PadVascular Solutions, Inc.20050—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K142363Nustat, Nustat XRBeeken Biomedical20154—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+4K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+4K080022Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc.20080—
+4K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K181641QuikClot RadialZ-Medica, LLC20180—
+5K160578Nustat XRBeeken Biomedical, LLC20160—
+5K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+5K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+5K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+5K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K202830Axiostat PatchAdvamedica, Inc.20210—
+6K182811gel-e Flex+Gel-E, Inc.20191—
+6K181696ChitoZolveGyrus Acmi, Inc.20180—
+6K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+6K141816HemoporePolyganics B.V.,20140—
+7K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+7K192667gel-e Flex+ gel OTCGel-E, Inc.20190—