# P970061: Scimed Radius Coronary Stent with Delivery System

- Pathway: PMA
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Jul 16, 1998 after 206 days
- Product code: MAF (Stent, Coronary)
- Device class: 3
- Recalls of this device: 3 (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
- Mar 17, 2003 · Not classified · Z-0776-03: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Mar 17, 2003 · Not classified · Z-0778-03: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Mar 17, 2003 · Not classified · Z-0777-03: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.

Source page: https://510kreport.com/device/P970061
Methodology: https://510kreport.com/methodology