# Arravasc, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 4 (2015–2017): 4 510(k) clearances
- Names in FDA's records: Arravasc, Ltd. (2); Arravasc Limited (2)
- Product codes: LIT (4)
- 510(k) review time since 2016: median 68 days, against 116 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 5 (2 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
- ClearStream Technologies, Ltd.: 2 (https://510kreport.com/company/clearstream-technologies)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Merit Medical Systems, Inc.: 3 (https://510kreport.com/company/merit-medical-systems)

## Its most-cited devices
- K151153: Pirouette 018 (2015), cited by 3
- K162316: Pirouette 014 (2016), cited by 1
- K161427: Pirouette 035 (2016), cited by 1

## Recent decisions
- K172033: Pirouette High Pressure (HP) (Aug 31, 2017)
- K162316: Pirouette 014 (Nov 22, 2016)
- K161427: Pirouette 035 (Jul 30, 2016)
- K151153: Pirouette 018 (Aug 20, 2015)

Source page: https://510kreport.com/company/arravasc