510(k) K960055

MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 by Pudenz-Schulte Medical Research Corp. — Product Code LJS

K960055 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932". The FDA issued a decision of Substantially Equivalent on September 30, 1996. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.