Cleared Traditional

K072117 - THROMBIX PATCH THROMBIN HEMOSTASIS PATCH

K072117 · Vascular Solutions, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
65d
Days
-
Risk

K072117 is an FDA 510(k) clearance for the THROMBIX PATCH THROMBIN HEMOSTASIS PATCH. 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 5, 2007 after a review of 65 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 K072117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date October 05, 2007
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 K072117.
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
K092612 · Vascular Solutions, Inc. · Sep 2009
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
K083190 · Vascular Solutions, Inc. · Nov 2008
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
K073264 · Vascular Solutions, Inc. · Dec 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
D-STAT DRY HEMOSTATIC BANDAGE
K061219 · Vascular Solutions, Inc. · Oct 2006