St. Jude Medical Systems AB
Country not established
- Devices
- 5
What St. Jude Medical Systems AB makes
The company manufactures pressure measurement catheters, including the PressureWire series (e.g., CERTUS, AERIS, and their agile-tip variants) for coronary physiology assessments, as well as Femostop occlusion systems (e.g., PLYS, HD, and compression arches) for vascular access management. Additional products include wireless receivers (AO USB Receiver, WI-BOX) and accompanying power supply kits for data acquisition and monitoring.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 Ref K140466
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does St. Jude Medical Systems AB have in the registry?
The registry currently lists 5 devices for St. Jude Medical Systems AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list St. Jude Medical Systems AB's devices?
Among its 5 most recently registered devices, St. Jude Medical Systems AB has devices listed in FDA 510(k) (5 devices).
What risk classes do St. Jude Medical Systems AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for St. Jude Medical Systems AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from St. Jude Medical Systems AB in the registry?
The most recently registered devices listed for St. Jude Medical Systems AB include PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300, FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F, AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER and PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300.