510(k) K860449

MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE by Top Corp. — Product Code FIE

K860449 is an FDA 510(k) premarket notification submitted by Top Corp. for the device "MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 26, 1986. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Top Corp. has 2 other 510(k) clearances on record.