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510(k) K070938

Device
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
Applicant
Vascular Solutions, Inc.
510(k) number
K070938
Product code
QSX
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-06
Date received
2007-04-04
Classification name
Hemostatic Wound Dressing With Thrombin Or Other Biologics
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JAMES CHAPMAN
Address
6464 Sycamore Ct. Minneapolis MN US 55369 55369

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200720D-Stat Radial Topical HemostatVascular Solutions, LLC2020-06-26
K102212D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVERVascular Solutions, Inc.2011-04-08
K092612D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505Vascular Solutions, Inc.2009-09-11
K083190D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015Vascular Solutions, Inc.2008-11-12
K073264D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005Vascular Solutions, Inc.2007-12-07
K072117THROMBIX PATCH THROMBIN HEMOSTASIS PATCHVascular Solutions, Inc.2007-10-05
K063860THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATVascular Solutions, Inc.2007-02-13
K061219D-STAT DRY HEMOSTATIC BANDAGEVascular Solutions, Inc.2006-10-06
K053644THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATVascular Solutions, Inc.2006-02-09
K053054THROMBIX 3X3 HEMOSTATIC PADVascular Solutions, Inc.2005-11-23
K050511THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATVascular Solutions, Inc.2005-04-14
K050133D-STAT RADIAL HEMOSTATIC BANDVascular Solutions, Inc.2005-02-18
K040510VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PADVascular Solutions, Inc.2004-03-17
K040118VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATICVascular Solutions, Inc.2004-02-12
K033709VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGEVascular Solutions, Inc.2003-12-18