510(k) K930218

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES by Concord/Portex — Product Code MAJ

K930218 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term), a Class II device regulated under 21 CFR 868.5120. Concord/Portex has at least 10 other 510(k) clearances on record.