# Strait Access Technologies Holdings

- Location (FDA's records): Cape Town, ZA
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: DQY (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)

## Recent decisions
- K243184: SAT CenterFlow Molding Balloon Catheter (IN20-00313) (Jun 25, 2025)

Source page: https://510kreport.com/company/strait-access-technologies-holdings