510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200720Substantially Equivalent

D-Stat Radial Topical Hemostat

Vascular Solutions LLC, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200720 is the FDA 510(k) clearance record for D-Stat Radial Topical Hemostat, cleared for Vascular Solutions, LLC on under FDA product code QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics). FDA's definition for product code QSX reads: "To temporarily control bleeding and cover external wounds". FDA records list 115 510(k) clearances for Vascular Solutions, LLC, from to . As of , FDA records show no recalls naming K200720.

Clearance record

Decision date
Received
(99 days to decision)
Product code
QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Vascular Solutions, LLC 6401 Sycamore Ct. N, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSX

Trailing 12 months

FDA records hold no clearances under product code QSX in the trailing twelve months.

FDA records show no clearances under product code QSX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260