Atlas FDA

QSX

18 FDA 510(k) clearances · Product code

44 daysmedian time to decision
184 days90th percentile
18clearances measured

FDA profile

Official device name
Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device class
Unclassified
Medical specialty
Unknown
FDA definition
To temporarily control bleeding and cover external wounds.
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RecordFirmDate
D-Stat Radial Topical Hemostat (K200720)Vascular Solutions, LLC2020-06-26
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER (K102212)Vascular Solutions, Inc.2011-04-08
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 (K092612)Vascular Solutions, Inc.2009-09-11
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 (K083190)Vascular Solutions, Inc.2008-11-12
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 (K073264)Vascular Solutions, Inc.2007-12-07
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH (K072117)Vascular Solutions, Inc.2007-10-05
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT (K070938)Vascular Solutions, Inc.2007-08-06
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K063860)Vascular Solutions, Inc.2007-02-13
D-STAT DRY HEMOSTATIC BANDAGE (K061219)Vascular Solutions, Inc.2006-10-06
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K053644)Vascular Solutions, Inc.2006-02-09
THROMBIX 3X3 HEMOSTATIC PAD (K053054)Vascular Solutions, Inc.2005-11-23
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K050511)Vascular Solutions, Inc.2005-04-14
D-STAT RADIAL HEMOSTATIC BAND (K050133)Vascular Solutions, Inc.2005-02-18
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD (K040510)Vascular Solutions, Inc.2004-03-17
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC (K040118)Vascular Solutions, Inc.2004-02-12
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE (K033709)Vascular Solutions, Inc.2003-12-18
D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE (K030836)Vascular Solutions, Inc.2003-09-17
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT (K012293)Vascular Solutions, Inc.2002-01-18

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Every clearance here is in the API, with alerts when new ones post.