Cleared Special

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

K200720 · Vascular Solutions, LLC · General & Plastic Surgery

Jun 2020

Decision

99d

Days

—

Risk

K200720 is an FDA 510(k) clearance for the D-Stat Radial Topical Hemostat, a Hemostatic Wound Dressing With Thrombin Or Other Biologics, submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on June 26, 2020, 99 days after receiving the submission on March 19, 2020. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K200720 FDA.gov
FDA Decision	Cleared 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

Device Classification

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