# P040044: Matrix Vascular Closure System (VSG)

- Pathway: PMA
- Applicant: Cordis US Corporation
- Decided: Aug 17, 2005 after 286 days
- Product code: MGB (Device, Hemostasis, Vascular)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 28, 2023 · Class II · Z-0674-2024: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as
- Nov 28, 2023 · Class II · Z-0675-2024: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as
- Jul 13, 2016 · Class II · Z-2329-2016: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Source page: https://510kreport.com/device/P040044
Methodology: https://510kreport.com/methodology