Cleared Traditional

K040510 - VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOS...

K040510 · Vascular Solutions, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
19d
Days
-
Risk

K040510 is an FDA 510(k) clearance for the VASCULAR SOLUTIONS D-STAT DRY 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 March 17, 2004 after a review of 19 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K040510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2004
Decision Date March 17, 2004
Days to Decision 19 days
Submission Type Traditional
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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K040510.
THROMBIX 3X3 HEMOSTATIC PAD
K053054 · Vascular Solutions, Inc. · Nov 2005
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 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
D-STAT-DRY HEMOSTATIC BANDAGE
K030836 · Vascular Solutions, Inc. · Sep 2003