ArteryFlow Technology Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 6
What ArteryFlow Technology Co., Ltd. makes
ArteryFlow Technology Co., Ltd. manufactures intravascular imaging and pressure-derived diagnostic devices, including intravascular ultrasound (IVUS) catheters (AccuCTP, AccuCTP Pro), fractional flow reserve (FFR) and pressure-derived analysis systems (AccuFFRangio, AccuFFRangio Plus), and an intravascular imaging guidance system (AneuGuide) for coronary and peripheral artery assessment.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices and is listed in the FDA’s 510(k) database. The company is headquartered in the United States.
Catalogue
AccuCTP Ref K220663
Regimes: 510(k) Registry: 510(k)AccuICAS Ref K221711
Regimes: 510(k) Registry: 510(k)AneuGuide Ref K213838
Regimes: 510(k) Registry: 510(k)AccuFFRangio Ref K210093
Regimes: 510(k) Registry: 510(k)AccuFFRangio Plus Ref K230303
Regimes: 510(k) Registry: 510(k)AccuCTP Pro Ref K231353
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does ArteryFlow Technology Co., Ltd. have in the registry?
The registry currently lists 6 devices for ArteryFlow Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ArteryFlow Technology Co., Ltd.'s devices?
Among its 6 most recently registered devices, ArteryFlow Technology Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do ArteryFlow Technology Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for ArteryFlow Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ArteryFlow Technology Co., Ltd. in the registry?
The most recently registered devices listed for ArteryFlow Technology Co., Ltd. include AccuCTP, AccuICAS, AneuGuide and AccuFFRangio.