510(k) K150800

Valved Safety Centesis Catheter by B.Braun Medical, Inc. — Product Code GCB

K150800 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Valved Safety Centesis Catheter". The FDA issued a decision of Substantially Equivalent on November 12, 2015. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.