# Guided Delivery Systems

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 2 (2009–2010): 2 510(k) clearances
- Product codes: DYB (1), DQY (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Enpath Medical, Inc.: 1 (https://510kreport.com/company/enpath-medical)

## Its most-cited devices
- K091367: GDS-DCS (2009), cited by 1

## Recent decisions
- K100135: GDS-DC12 (Apr 16, 2010)
- K091367: GDS-DCS (Nov 5, 2009)

Source page: https://510kreport.com/company/guided-delivery-systems