Advanced Bifurcation Systems, Inc.
Country not established
- Devices
- 1
What Advanced Bifurcation Systems, Inc. makes
Advanced Bifurcation Systems, Inc. manufactures coronary stents designed for percutaneous coronary intervention (PCI), including drug-eluting variants such as the SLENDER Sirolimus-Eluting Coronary Stent and the DIRECT Sirolimus-Eluting Coronary Stent. These devices incorporate rapid-exchange delivery systems for improved navigability in complex coronary bifurcations. The portfolio also includes integrated stent and catheter systems to enhance procedural efficiency in treating narrowed or blocked coronary arteries.
The company’s devices fall under FDA Class III regulation, requiring Premarket Approval (PMA) authorization. These products are listed in the FDA’s PMA registry. The manufacturer is based in the United States.
Catalogue
- Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Advanced Bifurcation Systems, Inc. have in the registry?
The registry currently lists 1 device for Advanced Bifurcation Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Bifurcation Systems, Inc.'s devices?
Among its 1 most recently registered device, Advanced Bifurcation Systems, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Advanced Bifurcation Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Advanced Bifurcation Systems, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Bifurcation Systems, Inc. in the registry?
The most recently registered devices listed for Advanced Bifurcation Systems, Inc. include SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex.