Cleared Special

K053054 - THROMBIX 3X3 HEMOSTATIC PAD

K053054 · Vascular Solutions, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2005
Decision
23d
Days
-
Risk

K053054 is an FDA 510(k) clearance for the THROMBIX 3X3 HEMOSTATIC PAD. 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 November 23, 2005 after a review of 23 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.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K053054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date November 23, 2005
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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.

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 K053054.
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K063860 · Vascular Solutions, Inc. · Feb 2007
D-STAT DRY HEMOSTATIC BANDAGE
K061219 · Vascular Solutions, Inc. · Oct 2006
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K053644 · Vascular Solutions, Inc. · Feb 2006
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K050511 · Vascular Solutions, Inc. · Apr 2005
D-STAT RADIAL HEMOSTATIC BAND
K050133 · Vascular Solutions, Inc. · Feb 2005
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
K040510 · Vascular Solutions, Inc. · Mar 2004