# Cardiogard Medical, Ltd.

- Location (FDA's records): Amherst, MA
- FDA decisions: 2 (2015–2019): 2 510(k) clearances
- Product codes: DWF (2)
- Predicates its devices cite: 6 (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
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Embol-X, Inc.: 2 (https://510kreport.com/company/embol-x)
- Edwards Lifesciences Research Medical: 1 (https://510kreport.com/company/edwards-lifesciences-research-medical)

## Its most-cited devices
- K141465: Cardiogard Emboli Protection Cannula (2015), cited by 1

## Recent decisions
- K182302: CardioGard Emboli Protection Cannula (May 17, 2019)
- K141465: Cardiogard Emboli Protection Cannula (Jan 9, 2015)

Source page: https://510kreport.com/company/cardiogard-medical