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QSX — Hemostatic Wound Dressing With Thrombin Or Other Biologics Class U

FDA Device Classification

Classification Details

Product Code
QSX
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
No

Definition

To temporarily control bleeding and cover external wounds.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200720vascular solutionsD-Stat Radial Topical HemostatJune 26, 2020
K102212vascular solutionsD-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILApril 8, 2011
K092612vascular solutionsD-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505September 11, 2009
K083190vascular solutionsD-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015November 12, 2008
K073264vascular solutionsD-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005December 7, 2007
K072117vascular solutionsTHROMBIX PATCH THROMBIN HEMOSTASIS PATCHOctober 5, 2007
K070938vascular solutionsTHROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTATAugust 6, 2007
K063860vascular solutionsTHROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATFebruary 13, 2007
K061219vascular solutionsD-STAT DRY HEMOSTATIC BANDAGEOctober 6, 2006
K053644vascular solutionsTHROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATFebruary 9, 2006
K053054vascular solutionsTHROMBIX 3X3 HEMOSTATIC PADNovember 23, 2005
K050511vascular solutionsTHROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATApril 14, 2005
K050133vascular solutionsD-STAT RADIAL HEMOSTATIC BANDFebruary 18, 2005
K040510vascular solutionsVASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PADMarch 17, 2004
K040118vascular solutionsVASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BFebruary 12, 2004
K033709vascular solutionsVASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGEDecember 18, 2003
K030836vascular solutionsD-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGESeptember 17, 2003
K012293vascular solutionsVASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTATJanuary 18, 2002