# P990037: Vascular Solutions Duett Sealing Device

- Pathway: PMA
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 22, 2000 after 358 days
- Product code: MGB (Device, Hemostasis, Vascular)
- Device class: 3
- Recalls of this device: 1 (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
- Apr 12, 2023 · Class II · Z-1611-2023: The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

Source page: https://510kreport.com/device/P990037
Methodology: https://510kreport.com/methodology