510(k) K873455

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS by Dravon Medical, Inc. — Product Code FJK

K873455 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on September 14, 1987. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.