# K221917: Stent Positioning Assistance System (SPAS)

- Pathway: 510(k) (Traditional)
- Applicant: Seven Sons, Ltd.
- Decided: Aug 19, 2022 after 50 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K854261 (1985). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141054: Distal Access Torque Device, Distal Access, LLC (2014) Summary page 4.

## Indications for use
SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures

Source page: https://510kreport.com/device/K221917
Methodology: https://510kreport.com/methodology