Cleared Special

K073264 - D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005

K073264 · Vascular Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
17d
Days
-
Risk

K073264 is an FDA 510(k) clearance for the D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005. Classified as Hemostatic Wound Dressing With Thrombin Or Other Biologics (product code QSX).

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 17 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073264

510(k) Number K073264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2007
Decision Date December 07, 2007
Days to Decision 17 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

QSX Device Classification - Class 0,

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

Regulatory Peers - QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics

All 17
Devices cleared under the same product code (QSX) and FDA review panel - the closest regulatory comparables to K073264.
D-STAT DRY SILVER
K102212 · Vascular Solutions, Inc. · Apr 2011
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
K092612 · Vascular Solutions, Inc. · Sep 2009
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
K083190 · Vascular Solutions, Inc. · Nov 2008
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
K072117 · Vascular Solutions, Inc. · Oct 2007
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
K070938 · Vascular Solutions, Inc. · Aug 2007
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K063860 · Vascular Solutions, Inc. · Feb 2007
K073264 · D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
Download PDF FDA Summary Vascular Solutions, I…