# K931386: Hemashield Microvel/Woven Double Velour Fabric

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: May 27, 1993 after 70 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
121 later devices descend from it; 1 cites it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch (1996), 120 descendants of its own
- K972651: IN-Sling (1997), 115 descendants of its own
- K980482: Triangle Sling (1998), 114 descendants of its own
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), 80 descendants of its own

Source page: https://510kreport.com/device/K931386
Methodology: https://510kreport.com/methodology