# P100013: Cordis Exoseal Vascular Closure Device

- Pathway: PMA
- Applicant: Cordis US Corporation
- Decided: May 19, 2011 after 413 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
- Oct 29, 2012 · Class II · Z-0740-2013: Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbe

Source page: https://510kreport.com/device/P100013
Methodology: https://510kreport.com/methodology