Cleared Traditional

K061219 - D-STAT DRY HEMOSTATIC BANDAGE

K061219 · Vascular Solutions, Inc. · General & Plastic Surgery device
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Oct 2006
Decision
158d
Days
-
Risk

K061219 is an FDA 510(k) clearance for the D-STAT DRY HEMOSTATIC BANDAGE. 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 October 6, 2006 after a review of 158 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K061219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date October 06, 2006
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K061219.
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
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K053644 · Vascular Solutions, Inc. · Feb 2006
THROMBIX 3X3 HEMOSTATIC PAD
K053054 · Vascular Solutions, Inc. · Nov 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K050511 · Vascular Solutions, Inc. · Apr 2005