NxStage Receives FDA 510(k) Clearance For Home Nocturnal Hemodialysis

by PRNewswire

Lawrence, MA /PRNewswire/ - NxStage Medical, Inc.(NASDAQ: NXTM), a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration (FDA) has 510(k) cleared its System One™ to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis. NxStage's® System One is the first and only hemodialysis machine 510(k) cleared by the FDA for this indication.

See the full article here.

Go to kBLASTER to FDA 510(k) search for a primary predicate, multiple predicates or reference devices, and harness kBLASTER's uniquely effective result management features, so you can quickly build a successful 510(k) clearance strategy.