510(k) K993187

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

K993187 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 November 5, 1999. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Diasol, Inc. has at least 9 other 510(k) clearances on record.