# P920004: Vasoseal (TM)

- Pathway: PMA
- Applicant: St. Jude Medical, Inc.
- Decided: Sep 29, 1995 after 1,334 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
- Jul 28, 2003 · Not classified · Z-0762-04: Kits are missing the temporary arteriotomy locator (TAL) from the blister package.

Source page: https://510kreport.com/device/P920004
Methodology: https://510kreport.com/methodology