Balt USA, LLC

Balt USA, LLC — FDA 510(k) Submissions

Balt USA, LLC has submitted 17 FDA 510(k) premarket notifications since 2018, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Device, Neurovascular Embolization, Catheter, Percutaneous, Neurovasculature, Catheter, Thrombus Retriever, Catheter, Continuous Flush, Device, Vascular, For Promoting Embolization . Use the specialty filter in the sidebar to narrow results.