# P030047: Cordis Precise Nitinol Stent System

- Pathway: PMA
- Applicant: Cordis US Corporation
- Decided: Sep 22, 2006 after 1,080 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 4 (1 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.
1 of 1 device in its family (counting itself) has 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 11, 2021 · Class I · Z-1257-2021: Distal tip may become separated from the lumen wire in specific lots.
- Nov 14, 2019 · Class II · Z-0729-2020: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- May 4, 2016 · Class II · Z-1947-2016: Inability to deploy the stent or partial stent deployment.
- May 4, 2016 · Class II · Z-1946-2016: Inability to deploy the stent or partial stent deployment.

Source page: https://510kreport.com/device/P030047
Methodology: https://510kreport.com/methodology