510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061219Substantially Equivalent

D-Stat Dry Hemostatic Bandage

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

K061219 is the FDA 510(k) clearance record for D-STAT DRY HEMOSTATIC BANDAGE, cleared for Vascular Solutions, Inc. 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, Inc., from to . As of , FDA records show no recalls naming K061219.

Clearance record

Decision date
Received
(158 days to decision)
Product code
QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Vascular Solutions, Inc. 6464 Sycamore Ct., Minneapolis 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