510(k) K031505

RAPIDO CUT-AWAY GUIDING CATHETER by Guidant Corporation — Product Code DQY

K031505 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "RAPIDO CUT-AWAY GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on June 25, 2003. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Guidant Corporation has at least 10 other 510(k) clearances on record.