510(k) K073326

NRG TRANSSEPTAL NEEDLE by Baylis Medical Co., Inc. — Product Code DXF

K073326 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "NRG TRANSSEPTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on May 28, 2008. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.