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510(k) K200720

D-Stat Radial Topical Hemostat by Vascular Solutions, LLC — Product Code QSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2020
Date Received
March 19, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

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Other clearances for product code QSX

  • K102212 — D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SIL (April 8, 2011)
  • K092612 — D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 (September 11, 2009)
  • K083190 — D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 (November 12, 2008)
  • K073264 — D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 (December 7, 2007)
  • K072117 — THROMBIX PATCH THROMBIN HEMOSTASIS PATCH (October 5, 2007)
  • K070938 — THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT (August 6, 2007)
  • K063860 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (February 13, 2007)
  • K061219 — D-STAT DRY HEMOSTATIC BANDAGE (October 6, 2006)
  • K053644 — THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (February 9, 2006)
  • K053054 — THROMBIX 3X3 HEMOSTATIC PAD (November 23, 2005)