510(k) K163073

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder by Sol-Millennium Medical, Inc. — Product Code JKA

K163073 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder". The FDA issued a decision of Substantially Equivalent on May 19, 2017. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.