# K930091: Cordis Reflex Steerable Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Apr 7, 1993 after 89 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 21, 2006 · Not classified · Z-1493-06: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
- Jul 21, 2006 · Not classified · Z-1492-06: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
- Jul 21, 2006 · Not classified · Z-1495-06: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
- Jul 21, 2006 · Not classified · Z-1494-06: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

Source page: https://510kreport.com/device/K930091
Methodology: https://510kreport.com/methodology