# P020026: Cypher Sirolimus-Eluting Coronary Stent on the Raptor Over-the-Wire Delivery System or Raptorrail Rapid Exchange Deliver

- Pathway: PMA
- Applicant: Cordis Corp.
- Decided: Apr 24, 2003 after 300 days
- Product code: NIQ (Coronary Drug-Eluting Stent)
- 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
- Jan 12, 2005 · Not classified · Z-0437-05: Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.

Source page: https://510kreport.com/device/P020026
Methodology: https://510kreport.com/methodology