# Callisyn Biomedical, Inc.

- Location (FDA's records): North Andover, MA
- FDA decisions: 1 (2017–2017): 1 510(k) clearance
- Product codes: KRA (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
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Recent decisions
- K161967: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (Jan 27, 2017)

Source page: https://510kreport.com/company/callisyn-biomedical