# K093729: Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva Antimicrobial Haemostatic IV Dressing, 1 I

- Pathway: 510(k) (Traditional)
- Applicant: Hemcon Medical Technologies Europe, Ltd.
- Decided: Jun 8, 2010 after 187 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953781 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 5.
- K072681: Bloodstop Hemostatic Gauze; IX Hemostatic Gauze, Lifescience Plus, Inc. (2007) Summary page 5.
- K010933: Seal-on Topical Hempstatic Powder Spray, Alltracel Pharma, Ltd. (2002) Summary page 5.

## Most influential descendants
- K121485: Guardiva Antimicrobial Haemstatic IV Dressing (2012), 0 descendants of its own

## Indications for use
The HemCon GuardlVa Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.

Source page: https://510kreport.com/device/K093729
Methodology: https://510kreport.com/methodology