# St. Jude Medical Systems AB

- Location (FDA's records): Uppsala, SE
- FDA decisions: 5 (2011–2014): 5 510(k) clearances
- Product codes: DRG (2), DXO (2), DXC (1)
- Predicates its devices cite: 8 (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
- Radi Medical Systems AB: 4 (https://510kreport.com/company/radi-medical-systems)
- Kingyield Hongkong Limited: 1 (https://510kreport.com/company/kingyield-hongkong)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)

## Firms that cite its devices most
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Zurich Medical, Inc.: 1 (https://510kreport.com/company/zurich-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), cited by 4
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 (2014), cited by 1

## Recent decisions
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 (Nov 13, 2014)
- K133587: Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300 (Dec 20, 2013)
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (Sep 5, 2013)
- K111854: AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver (Oct 21, 2011)
- K110193: Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch, Bilateral Adapter; F (Feb 24, 2011)

Source page: https://510kreport.com/company/st-jude-medical-systems