# K955349: Hemashield Knitted Double Velour Cardiovascular Fabric

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Feb 14, 1996 after 85 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch (1996), 3 descendants of its own
- K112683: Smi Cardiovascular Pach (2011), 1 descendant of its own
- K122105: Smi Cardiovascular Patch (2012), 0 descendants of its own
- K101740: Albosure Polyester Vascular Patch (2010), 0 descendants of its own

## Recalls of this device
- Jan 3, 2018 · Class II · Z-1172-2018: A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm 
- May 24, 2010 · Not classified · Z-2062-2010: Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially com

Source page: https://510kreport.com/device/K955349
Methodology: https://510kreport.com/methodology