Cleared Special

K200720 - D-Stat Radial Topical Hemostat (FDA 510(k) Clearance)

K200720 · Vascular Solutions, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2020
Decision
99d
Days
-
Risk

K200720 is an FDA 510(k) clearance for the D-Stat Radial Topical Hemostat. Classified as Hemostatic Wound Dressing With Thrombin Or Other Biologics (product code QSX).

Submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on June 26, 2020 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K200720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2020
Decision Date June 26, 2020
Days to Decision 99 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 114d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.