510(k) K171584

B. Braun Tear-Away Introducer Needle by B.Braun Medical, Inc. — Product Code BSO

K171584 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "B. Braun Tear-Away Introducer Needle". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.