# Cardiosolutions, Inc.

- Location (FDA's records): West Bridgewater, MA
- FDA decisions: 5 (2010–2014): 5 510(k) clearances
- Names in FDA's records: Cardiosolutions, Inc. (4); Cardiosolutions (1)
- Product codes: DYB (2), DYG (1), DQX (1), DRA (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 3 (3 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
- Techdevice Corporation: 2 (https://510kreport.com/company/techdevice)
- Boston Scientific Scimed, Inc.: 1 (https://510kreport.com/company/boston-scientific-scimed)
- Boston Scientific, Target: 1 (https://510kreport.com/company/boston-scientific-target)
- Biosensors Intl. Pte., Ltd.: 1 (https://510kreport.com/company/biosensors-intl)
- Tfx Medical Group: 1 (https://510kreport.com/company/tfx-medical-group)
- St. Jude Medical, Daig Division, Inc.: 1 (https://510kreport.com/company/st-jude-medical-daig-division)
- Evalve, Inc.: 1 (https://510kreport.com/company/evalve)

## Its most-cited devices
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (2012), cited by 2
- K131332: Cardiosolutions Percu-Pro Steerable Introducer (2013), cited by 1

## Recent decisions
- K140015: Cardiosolutions Dexterity Steerable Introducer (Feb 5, 2014)
- K131332: Cardiosolutions Percu-Pro Steerable Introducer (Jul 19, 2013)
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (Apr 24, 2012)
- K094048: Percupro Messenger Balloon Catheter (Jul 14, 2011)
- K094062: Percu-Pro Guidewire (Sep 27, 2010)

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