SZYJ Medical Technology Group is a global market leader in the R&D and manufacturing of PCI/PTA balloons
The Products:
High performance PCI/PTA balloon, stent and special catheter
2017,SZYJ commenced selling the PCI/PTA balloon products in the United States.
2018 PTA received FDA 510(k) clearance.
Sapphire II Pro received FDA 510(k) clearance in March and became the first 1.0mm diameter balloon in the United States.
The microcatheter product, obtained CE Mark and FDA 510(k) clearance in March and November, respectively.
2019 The latest generation Sapphire 3 obtained approval from PMDA in January.
PTA received FDA 510(k) clearance in May.
COMBO Plus dual therapy stent obtained approval from PMDA.
2020 Sapphire 3 and Sapphire NC 24 received CE Mark in March.
Dual therapy stent obtained NMPA approval in August.
2021,Sapphire II Pro OTW version and Jade PTA 14”/18”/35” OTW series were launched in the United States.