510(k) K241058

Lyka® PORT Needle Free Access Device (4170Y) by Quest Medical, Inc. — Product Code FPA

K241058 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "Lyka® PORT Needle Free Access Device (4170Y)". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.