Cleared Special

K050133 - D-STAT RADIAL HEMOSTATIC BAND

K050133 · 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
Feb 2005
Decision
28d
Days
-
Risk

K050133 is an FDA 510(k) clearance for the D-STAT RADIAL HEMOSTATIC BAND. 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 February 18, 2005 after a review of 28 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 - K050133

510(k) Number K050133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2005
Decision Date February 18, 2005
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 K050133.
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
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
K040510 · Vascular Solutions, Inc. · Mar 2004
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
K040118 · Vascular Solutions, Inc. · Feb 2004
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
K033709 · Vascular Solutions, Inc. · Dec 2003
K050133 · D-STAT RADIAL HEMOSTATIC BAND
Download PDF FDA Summary Vascular Solutions, I…