510(k) K951098

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER by Hdc Corp. — Product Code LJS

K951098 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER". The FDA issued a decision of Substantially Equivalent on June 2, 1995. 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. Hdc Corp. has at least 10 other 510(k) clearances on record.