510(k) K831386

GROSHONG CATHETER, LONG TERM TYPE by Catheter Technology Corp. — Product Code LJS

K831386 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "GROSHONG CATHETER, LONG TERM TYPE". The FDA issued a decision of Substantially Equivalent on October 14, 1983. 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. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.