510(k) K000955

PLACER MODEL 6232 STEERABLE STYLET by Medtronic Vascular — Product Code DRB

K000955 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "PLACER MODEL 6232 STEERABLE STYLET". The FDA issued a decision of Substantially Equivalent on June 16, 2000. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Medtronic Vascular has at least 10 other 510(k) clearances on record.