510(k) K921755

8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS by Davol, Inc. — Product Code LJS

K921755 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS". The FDA issued a decision of Substantially Equivalent on October 23, 1992. 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. Davol, Inc. has at least 10 other 510(k) clearances on record.