Cleared Special

K040118 - VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC

K040118 · 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 2004
Decision
23d
Days
-
Risk

K040118 is an FDA 510(k) clearance for the VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATI.... 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 12, 2004 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.

FDA 510(k) Submission Details - K040118

510(k) Number K040118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date February 12, 2004
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.

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 K040118.
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
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
K033709 · Vascular Solutions, Inc. · Dec 2003
D-STAT-DRY HEMOSTATIC BANDAGE
K030836 · Vascular Solutions, Inc. · Sep 2003
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
K012293 · Vascular Solutions, Inc. · Jan 2002
K040118 · VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
Download PDF FDA Summary Vascular Solutions, I…