510(k) K931048

4-SURE NELATON CATHETER by Boston Pacific Medical, Inc. — Product Code EZD

K931048 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4-SURE NELATON CATHETER". The FDA issued a decision of Substantially Equivalent on February 14, 1994. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.