510(k) K992653

SHELLY PROTECTED AV FISTULA NEEDLE by Diasol, Inc. — Product Code FIE

K992653 is an FDA 510(k) premarket notification submitted by Diasol, Inc. for the device "SHELLY PROTECTED AV FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on October 27, 1999. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Diasol, Inc. has at least 9 other 510(k) clearances on record.