# P050007: Starclose Vascular Closure System

- Pathway: PMA
- Applicant: Abbott Vascular Devices
- Decided: Dec 21, 2005 after 296 days
- Product code: MGB (Device, Hemostasis, Vascular)
- Device class: 3
- 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.
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
- Feb 10, 2017 · Class II · Z-1202-2017: Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
- May 6, 2009 · Not classified · Z-1657-2009: Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.

Source page: https://510kreport.com/device/P050007
Methodology: https://510kreport.com/methodology