# P040012: Acculink Carotid Stent System and RX Acculink Carotid Stent System

- Pathway: PMA
- Applicant: Abbott Vascular
- Decided: Aug 30, 2004 after 168 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 4 (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
- Sep 10, 2010 · Not classified · Z-0337-2011: The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If t
- Sep 10, 2010 · Not classified · Z-0338-2011: The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If t
- Sep 10, 2010 · Not classified · Z-0339-2011: The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If t
- Oct 1, 2009 · Not classified · Z-0749-2010: The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.

Source page: https://510kreport.com/device/P040012
Methodology: https://510kreport.com/methodology